510(k) · Cleared
Recalled · Class II · 2025Intuitive Surgical DA Vinci Surgical System, Model IS2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical, Inc. · NAY System, Surgical, Computer Controlled Instrument
Cleared on Apr 29, 2005 as substantially equivalent to K990144 (Intuitive Surgical, Inc., 2000) and 7 other predicates after a 74-day review. Its family tree reaches back 6 generations to 1994. 1 of the 258 devices in its family, counting itself, has a Class I recall. 230 later devices descend from it. It has been recalled 51 times.
- Decided
- Apr 29, 2005
- Review
- 74 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 51
- Predicates
- 9
Its longest line of descent runs back 6 generations to K930667 (1994). 27 ancestors in all, the oldest K811390 (1981). 230 later devices descend from it, 20 citing it directly. 1 of the 258 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 5 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 4 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 3 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 2 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 1 generation backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- This deviceK050369 Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc. · 2005
- Descendant · cites it directly · 228 of its ownK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- Descendant · cites it directly · 224 of its ownK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- Descendant · cites it directly · 211 of its ownK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- Descendant · cites it directly · 155 of its ownK060391 Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 2006 · Recalled
- Descendant · cites it directly · 154 of its ownK061260 Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 &…Intuitive Surgical, Inc. · 2006 · Recalled
Showing 5 of 230 descendants. See all descendants
Descendants cleared per year
2005high 31 (2025) · low 0 (2007)2026
Class I recalls in this family
- K223095 Senhance Surgical System3 generations on · 2023
Most influential descendants
Showing 5 of 230 · See all- K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · cites it directly228descendants
- K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · cites it directly224descendants
- K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · cites it directly211descendants
- K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 2006 · cites it directly155descendants
- K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc. · 2006 · cites it directly154descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −5 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −4 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −3 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −2 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −1 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| 0 (this device) | K050369 | Intuitive Surgical DA Vinci Surgical System, Model IS2000 | Intuitive Surgical, Inc. | 2005 | — |
| +1 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| +1 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| +1 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| +1 | K060391 | Intuitive Surgical Endowrist Stabilizer, Model 420182 | Intuitive Surgical, Inc. | 2006 | 1 |
| +1 | K061260 | Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214 | Intuitive Surgical, Inc. | 2006 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 9 | 0 |
| 2015 | 4 | 0 |
| 2016 | 9 | 0 |
| 2017 | 14 | 0 |
| 2018 | 17 | 0 |
| 2019 | 9 | 0 |
| 2020 | 17 | 0 |
| 2021 | 16 | 0 |
| 2022 | 18 | 0 |
| 2023 | 19 | 1 |
| 2024 | 22 | 0 |
| 2025 | 31 | 0 |
| 2026 | 22 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NAY device
- #1 K232610 da Vinci Surgical System Model IS5000, da…score 32.9 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…Summary page 1…d accessonies Predicate Intuitive Surgical (la Vinci Surgical System and Endoscopic Inslrumcnts IDcvices (legally marketed under K990 144 / K00)2489 / KOI 1002 / K01 3416/ K021036 / K022574 / K040237 I K043 153 / KO5OCO5) Device… | 2000 |
| * | K002489 | Intuitive Surgical DA Vinci Endoscopic Control System | 2001 |
| * | K011002 | Intuitive Surgical DA Vinci Surgical System, Model Isi 1000 | 2001 |
| * | K013416 | Intuitive Surgical Endowrist Endoscopic Instrument FamilySummary page 1…Intuitive Surgical (la Vinci Surgical System and Endoscopic Inslrumcnts IDcvices (legally marketed under K990 144 / K00)2489 / KOI 1002 / K01 3416/ K021036 / K022574 / K040237 I K043 153 / KO5OCO5) Device The da Vinci Surgic… | 2002 |
| * | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000Summary page 1…i Surgical System and Endoscopic Inslrumcnts IDcvices (legally marketed under K990 144 / K00)2489 / KOI 1002 / K01 3416/ K021036 / K022574 / K040237 I K043 153 / KO5OCO5) Device The da Vinci Surgical System, consists of three integra.t… | 2002 |
| * | K022574 | Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…Summary page 1…System and Endoscopic Inslrumcnts IDcvices (legally marketed under K990 144 / K00)2489 / KOI 1002 / K01 3416/ K021036 / K022574 / K040237 I K043 153 / KO5OCO5) Device The da Vinci Surgical System, consists of three integra.ted sub-sys… | 2002 |
| * | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…Summary page 1…d Endoscopic Inslrumcnts IDcvices (legally marketed under K990 144 / K00)2489 / KOI 1002 / K01 3416/ K021036 / K022574 / K040237 I K043 153 / KO5OCO5) Device The da Vinci Surgical System, consists of three integra.ted sub-systems as De… | 2004 |
| * | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…Summary page 1…ic Inslrumcnts IDcvices (legally marketed under K990 144 / K00)2489 / KOI 1002 / K01 3416/ K021036 / K022574 / K040237 I K043 153 / KO5OCO5) Device The da Vinci Surgical System, consists of three integra.ted sub-systems as Description… | 2004 |
| Kept off the family tree | K050005 | FDA’s K050005 is Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2005 |
What descends from it? (230)
See all 23020 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | 2005 | 228 |
| K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | 2006 | 224 |
| K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | 2009 | 211 |
| K060391 | Intuitive Surgical Endowrist Stabilizer, Model 420182 | 2006 | 155 |
| K061260 | Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214 | 2006 | 154 |
| K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000 | 2009 | 153 |
| K131962 | DA Vinci SP Surgical System, Endowrist SP Instruments, and Accessories | 2014 | 22 |
| K081207 | Intuitive Surgical DA Vinci S Surgical System, Model IS2000, with DA Vinci Connect and… | 2008 | 7 |
| K123329 | DA Vinvi Surgical System | 2014 | 3 |
| K180033 | 8mm Monopolar Curved Scissors | 2018 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 9, 2025 | Class II | Z-1701-2026 | Process change control | Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments |
| Dec 9, 2025 | Class II | Z-1699-2026 | Process control | Due to increased complaints for broken/frayed grip cables for reusable instruments. |
| Dec 9, 2025 | Class II | Z-1697-2026 | Process control | Due to increased complaints for broken/frayed grip cables for reusable instruments. |
| Dec 9, 2025 | Class II | Z-1696-2026 | Process control | Due to increased complaints for broken/frayed grip cables for reusable instruments. |
| Dec 9, 2025 | Class II | Z-1700-2026 | Process change control | Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments |
| Dec 9, 2025 | Class II | Z-1698-2026 | Process control | Due to increased complaints for broken/frayed grip cables for reusable instruments. |
| Jul 1, 2022 | Class II | Z-1459-2022 | Nonconforming Material/Component | Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system. |
| Aug 15, 2018 | Class II | Z-3024-2018 | Use error | Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the… |
| Mar 16, 2016 | Class II | Z-1376-2016 | Device Design | Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large Needle Driver Instrument) to manipulate the ablation probes during cardiac surgery can result in an increase of microscopic metallic… |
| May 21, 2015 | Class II | Z-1812-2015 | Nonconforming Material/Component | The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of fragments of coating material dislodging and potentially falling into patient. |
| Jun 13, 2014 | Class II | Z-2020-2014 | Process control | Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the instrument jamming during insertion when used with the 8 mm cannula or with certain reducer accessories.. |
| May 21, 2014 | Class II | Z-1966-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1967-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1970-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1972-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1971-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1974-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1964-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1968-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1975-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1969-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1973-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1965-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| Nov 15, 2013 | Class II | Z-0521-2014 | Software design (manufacturing process) | Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers. |
| Nov 15, 2013 | Class II | Z-0520-2014 | Software design (manufacturing process) | Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers. |
| Nov 11, 2013 | Class II | Z-0436-2014 | Device Design | Reports of friction within certain instrument arms can interrupt smooth instrument motion. This can be felt by the surgeon as resistance in the movement of the master.In this situation, the instrument can stall momentarily and then… |
| May 6, 2013 | Class II | Z-1463-2013 | Use error | Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262). |
| Mar 15, 2013 | Class II | Z-1109-2013 | Nonconforming Material/Component | Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation. |
| Jul 13, 2012 | Class II | Z-2104-2012 | Nonconforming Material/Component | Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. |
| Jul 13, 2012 | Class II | Z-2103-2012 | Nonconforming Material/Component | Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. |
| Jul 13, 2012 | Class II | Z-2105-2012 | Nonconforming Material/Component | Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. |
| Jul 13, 2012 | Class II | Z-2102-2012 | Nonconforming Material/Component | Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. |
| Jul 13, 2012 | Class II | Z-2106-2012 | Nonconforming Material/Component | Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. |
| Jul 13, 2012 | Class II | Z-2101-2012 | Nonconforming Material/Component | Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. |
| Apr 27, 2012 | Class II | Z-1994-2014 | Device Design | Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging. |
| Sep 19, 2011 | Class II | Z-1428-2013 | Labeling False and Misleading | Clarification of existing labeling information and operating procedures. |
| Sep 19, 2011 | Class II | Z-1427-2013 | Labeling False and Misleading | Clarification of existing labeling information and operating procedures. |
| Sep 19, 2011 | Class II | Z-1429-2013 | Labeling False and Misleading | Clarification of existing labeling information and operating procedures. |
| Jul 15, 2009 | Not classified | Z-1161-2010 | Software design | Gripper or Scissor jaws may close inadvertently, and will not open on command and various other reported modes of failure. Control by surgeon may fail and this failure may be difficult to detect. |
| Jun 1, 2008 | Not classified | Z-2204-2008 | Software design (manufacturing process) | Defective software chip may cause the system to fail and lock up. |
| Dec 27, 2007 | Not classified | Z-1180-2008 | Software design | Delay in responding: In certain circumstances, the device may not respond immediately to a user's command such as master clutch or camera control. |
| Nov 19, 2007 | Not classified | Z-0669-2008 | Other | Sharp Edges: the 5mm Cannula may have a sharp edge on the inner diameter of the Cannula. The defective cannulae may cause particulate shavings to be skive (scraping) from the instrument shafts during surgery. |
| Oct 4, 2007 | Not classified | Z-0151-2008 | Mixed-up of materials/components | Under-Rated Fuses--The Firm may have installed incorrect fuses. The daVinci Surgical System Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a 5A fuse for 230V operation. Operation of this product with the use… |
| Oct 4, 2007 | Not classified | Z-0152-2008 | Mixed-up of materials/components | Under-Rated Fuses -- The Firm may have installed incorrect fuses. The daVinci Surgical System Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a 5A fuse for 230V operation. Operation of this product with the… |
| May 14, 2007 | Not classified | Z-1245-2007 | Process control | Product may malfunction and fail to start up on AC power. |
| Mar 30, 2007 | Not classified | Z-0079-2008 | Software design | System Lock-Up: Software anomalies could cause product failure during use, or on start-up. System transitions to a safe "soft-lock" state. |
| Mar 9, 2007 | Not classified | Z-0657-2008 | Nonconforming Material/Component | Devices may have a ridge on the side of the cannula, which has the potential to abrade instrument shafts and generate black particulate matter. |
| Mar 9, 2007 | Not classified | Z-0658-2008 | Nonconforming Material/Component | Devices may have a ridge on the side of the cannula, which has the potential to abrade instrument shafts and generate black particulate matter. |
| Mar 9, 2007 | Not classified | Z-0659-2008 | Nonconforming Material/Component | Devices may have a ridge on the side of the cannula, which has the potential to abrade instrument shafts and generate black particulate matter. |
| Apr 12, 2006 | Not classified | Z-0670-2007 | Other | Da Vinci S Surgical System's spinal pin could limit mechanical motion of the arm and render the system unavailable for surgical use, and may result in system failure and the need to convert to an alternative surgical technique. |
The 5 latest of 50 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 27 ancestors have a recall of any class.
- Of its descendants, K050802 (Intuitive Surgical, Inc., 2005) has gone furthest, with 228 descendants of its own.
- 20 other devices also cite its predicate K990144.
How does its category compare?
All NAY devicesNAY System, Surgical, Computer Controlled Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NAY
16in 2025
2007high 16 (2017) · low 0 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · NAY
117in 2025
2007high 253 (2009) · low 57 (2022)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NAY
1in 2025
2007high 40 (2024) · low 0 (2010)2026
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NAY
48,456in 2025
2007high 48,456 (2025) · low 133 (2007)2025
MAUDE reports naming product code NAY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 11 | 133 |
| 2008 | 4 | 189 | 3 | 224 |
| 2009 | 3 | 253 | 1 | 380 |
| 2010 | 1 | — | 0 | 623 |
| 2011 | 7 | 191 | 2 | 501 |
| 2012 | 4 | 106 | 1 | 1,552 |
| 2013 | 4 | 144 | 6 | 6,217 |
| 2014 | 9 | 143 | 25 | 6,135 |
| 2015 | 3 | 99 | 3 | 1,722 |
| 2016 | 8 | 197 | 1 | 1,077 |
| 2017 | 16 | 107 | 1 | 1,049 |
| 2018 | 15 | 152 | 2 | 1,074 |
| 2019 | 8 | 73 | 5 | 1,154 |
| 2020 | 9 | 212 | 0 | 1,558 |
| 2021 | 11 | 61 | 3 | 1,997 |
| 2022 | 6 | 57 | 3 | 5,727 |
| 2023 | 5 | 141 | 2 (1) | 10,898 |
| 2024 | 10 | 126 | 40 | 12,872 |
| 2025 | 16 | 117 | 1 | 48,456 |
| 2026 | 7 | 89 | 4 (1) | — |
What is it indicated for?
The Intuitive Surgical™ da Vinei® Surgical System is intended to assist in the accurate control of Intuitive Surgical™ Endoscopic Instruments including rigid endoscopes, bluni and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears. forceps/pick-ups, needle holders. endoscopic retractors, stabilizers, clectrocautcry and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection.…
Read the full statement (133 words)
The Intuitive Surgical™ da Vinei® Surgical System is intended to assist in the accurate control of Intuitive Surgical™ Endoscopic Instruments including rigid endoscopes, bluni and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears. forceps/pick-ups, needle holders. endoscopic retractors, stabilizers, clectrocautcry and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection. approximation, ligation, clectrocautcry, suturing, and delivery and placement of microwave ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac rcvascularization. It is intended for usC by trained physiciaas in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050369 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050369: Intuitive Surgical DA Vinci Surgical System, Model IS2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050369
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026