510(k) · Cleared
Recalled · Class II · 2015Intuitive Surgical DA Vinci Endoscopic Instruments and Control System and Endowrist Stabilizer
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 Mar 19, 2008 as substantially equivalent to K040237 (Intuitive Surgical, Inc., 2004) and 2 other predicates after a 44-day review. Its family tree reaches back 10 generations to 1994. It has been recalled once.
- Decided
- Mar 19, 2008
- Review
- 44 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 10 generations to K930667 (1994). 47 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet.
- Root · 10 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 6 generations between
- 3 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 2 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 1 generation backK060391 Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 2006 · Recalled
- This deviceK080291 Intuitive Surgical DA Vinci Endoscopic Instruments and Control…Intuitive Surgical, Inc. · 2008
Show all 10 generations
- Root · 10 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 9 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 8 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 7 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 6 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 5 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 4 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 3 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 2 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 1 generation backK060391 Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 2006 · Recalled
- This deviceK080291 Intuitive Surgical DA Vinci Endoscopic Instruments and Control…Intuitive Surgical, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −9 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −8 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −7 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −6 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −5 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −4 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −3 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −2 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −1 | K060391 | Intuitive Surgical Endowrist Stabilizer, Model 420182 | Intuitive Surgical, Inc. | 2006 | 1 |
| 0 (this device) | K080291 | Intuitive Surgical DA Vinci Endoscopic Instruments and Control System and… | Intuitive Surgical, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 7 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 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.
Planning a device in NAY? 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? (3)
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 |
|---|---|---|---|
| * | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…Summary page 1…Class II per 876.1500 - Endoscope and Accessories Product Codes: NAY Predicate Devices: Intuitive Surgical da Vinci Surgical System (K040237), the d/a Vinci S Surgical System (K050369), and the Endo~rist St… | 2004 |
| * | K050369 | Intuitive Surgical DA Vinci Surgical System, Model IS2000Summary page 1…NAY Predicate Devices: Intuitive Surgical da Vinci Surgical System (K040237), the d/a Vinci S Surgical System (K050369), and the Endo~rist Stabilizer (K06039 1) IDevice Description: 1. The da Vinci Surgical System… | 2005 |
| * | K060391 | Intuitive Surgical Endowrist Stabilizer, Model 420182Summary page 1…Vinci Surgical System (K040237), the d/a Vinci S Surgical System (K050369), and the Endo~rist Stabilizer (K06039 1) IDevice Description: 1. The da Vinci Surgical System consists of three integrated sob-systems as follows: Endoscopie Instr… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 16, 2015 | Class II | Z-1226-2015 | Under Investigation by firm | There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterility of the pouches outer surface. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 47 ancestors have a recall of any class.
- 11 other devices also cite its predicate K040237.
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. 2008, this device’s year, is highlighted.
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, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation…
Read the full statement (169 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, 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 and suturing 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 to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the 4rth arm da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery. It is intended to be used only by medical professionals in operating room environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080291 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080291: Intuitive Surgical DA Vinci Endoscopic Instruments and Control System and Endowrist Stabilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080291
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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