510(k) · Cleared
Recalled · Class II · 2013Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model 400180
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 Jan 25, 2005 as substantially equivalent to K990144 (Intuitive Surgical, Inc., 2000) and 7 other predicates after a 22-day review. Its family tree reaches back 6 generations to 1994. 1 of the 259 devices in its family, counting itself, has a Class I recall. 231 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 25, 2005
- Review
- 22 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 2
- Predicates
- 8
Its longest line of descent runs back 6 generations to K930667 (1994). 27 ancestors in all, the oldest K811390 (1981). 231 later devices descend from it, 7 citing it directly. 1 of the 259 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 deviceK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005
- Descendant · cites it directly · 229 of its ownK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive 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 · 2 generations on · 224 of its ownK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 211 of its ownK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 155 of its ownK060391 Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 2006 · Recalled
Showing 5 of 231 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K223095 Senhance Surgical System3 generations on · 2023
Most influential descendants
Showing 5 of 231 · See all- K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · cites it directly229descendants
- 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 · 2 generations on224descendants
- K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · 3 generations on211descendants
- K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 2006 · 2 generations on155descendants
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) | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | — |
| +1 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| +1 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| +2 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| +3 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| +2 | K060391 | Intuitive Surgical Endowrist Stabilizer, Model 420182 | 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 | 2 | 0 |
| 2006 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 9 | 0 |
| 2015 | 4 | 0 |
| 2016 | 9 | 0 |
| 2017 | 14 | 0 |
| 2018 | 16 | 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? (8)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…Summary page 1…polar Curved Scissors Predicate Intuitive Surgical® da Vinci ® Surgical System and Endoscopic Devices Instruments (legally marketed under K990144 / K002489 / K011002 / K013416 / K021036 / K022574 / K040237 / K043153) Device This spec… | 2000 |
| * | K002489 | Intuitive Surgical DA Vinci Endoscopic Control SystemSummary page 1…ed Scissors Predicate Intuitive Surgical® da Vinci ® Surgical System and Endoscopic Devices Instruments (legally marketed under K990144 / K002489 / K011002 / K013416 / K021036 / K022574 / K040237 / K043153) Device This special 510(k)… | 2001 |
| * | K011002 | Intuitive Surgical DA Vinci Surgical System, Model Isi 1000Summary page 1…s Predicate Intuitive Surgical® da Vinci ® Surgical System and Endoscopic Devices Instruments (legally marketed under K990144 / K002489 / K011002 / K013416 / K021036 / K022574 / K040237 / K043153) Device This special 510(k) is being… | 2001 |
| * | K013416 | Intuitive Surgical Endowrist Endoscopic Instrument FamilySummary page 1…ive Surgical® da Vinci ® Surgical System and Endoscopic Devices Instruments (legally marketed under K990144 / K002489 / K011002 / K013416 / K021036 / K022574 / K040237 / K043153) Device This special 510(k) is being submitted for a modification to th… | 2002 |
| * | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000Summary page 1…al® da Vinci ® Surgical System and Endoscopic Devices Instruments (legally marketed under K990144 / K002489 / K011002 / K013416 / K021036 / K022574 / K040237 / K043153) Device This special 510(k) is being submitted for a modification to the Descript… | 2002 |
| * | K022574 | Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…Summary page 1…ci ® Surgical System and Endoscopic Devices Instruments (legally marketed under K990144 / K002489 / K011002 / K013416 / K021036 / K022574 / K040237 / K043153) Device This special 510(k) is being submitted for a modification to the Description… | 2002 |
| * | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…Summary page 1…cal System and Endoscopic Devices Instruments (legally marketed under K990144 / K002489 / K011002 / K013416 / K021036 / K022574 / K040237 / K043153) Device This special 510(k) is being submitted for a modification to the Description endo… | 2004 |
| * | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…Summary page 1…and Endoscopic Devices Instruments (legally marketed under K990144 / K002489 / K011002 / K013416 / K021036 / K022574 / K040237 / K043153) Device This special 510(k) is being submitted for a modification to the Description endoscopic ins… | 2004 |
What descends from it? (231)
See all 2317 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | 2005 | 229 |
| K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | 2005 | 228 |
| K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000 | 2009 | 153 |
| K112263 | Monopolar Curved Scissors Tip Cover Accessory | 2011 | 27 |
| K082497 | Intuitive Surgical Endowrist One Hot Shears Instrument | 2009 | 23 |
| K131962 | DA Vinci SP Surgical System, Endowrist SP Instruments, and Accessories | 2014 | 22 |
| K123329 | DA Vinvi Surgical System | 2014 | 3 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 8, 2013 | Class II | Z-1442-2013 | Nonconforming Material/Component | Intuitive Surgical has identified a potential for some units of the Monopolar curved Scissors version 09 and 10 instruments to develop very small cracks near the distal end. This may create a pathway for electrosurgical energy to leak to… |
| Sep 23, 2011 | Class II | Z-1425-2013 | Device Design | Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System. |
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, K050404 (Intuitive Surgical, Inc., 2005) has gone furthest, with 229 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
2026 to Oct 25, outlined.
Median 510(k) review, days · NAY
117in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NAY
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NAY
48,456in 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®Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical®Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection…
Read the full statement (124 words)
The Intuitive Surgical®Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical®Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories during general 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 revascularization. It is intended for use by trained physicians 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/K050005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050005: Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model 400180.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050005
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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