510(k) · Cleared
Recalled · 2008Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist Cardiac Probe Grasper
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 Feb 14, 2008 as substantially equivalent to K990144 (Intuitive Surgical, Inc., 2000) and 14 other predicates after a 316-day review. Its family tree reaches back 10 generations to 1994. It has been recalled once.
- Decided
- Feb 14, 2008
- Review
- 316 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 1
- Predicates
- 16
Its longest line of descent runs back 10 generations to K930667 (1994). 80 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 backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- This deviceK070947 Intuitive Surgical DA Vinci Surgical System and Endoscopic…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 backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- This deviceK070947 Intuitive Surgical DA Vinci Surgical System and Endoscopic…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 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| 0 (this device) | K070947 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and… | Intuitive Surgical, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 6 | 0 |
| 1996 | 2 | 0 |
| 1997 | 11 | 0 |
| 1998 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 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? (16)
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 2…redicate Intuitive Surgical da Vinci ¢ Surgical System and Endoscopic Devices Instruments (legally marketed underK990144, K002489, KO1 1002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802 and… | 2000 |
| * | K002489 | Intuitive Surgical DA Vinci Endoscopic Control SystemSummary page 2…Intuitive Surgical da Vinci ¢ Surgical System and Endoscopic Devices Instruments (legally marketed underK990144, K002489, KO1 1002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802 and… | 2001 |
| * | K011002 | Intuitive Surgical DA Vinci Surgical System, Model Isi 1000 | 2001 |
| * | K013416 | Intuitive Surgical Endowrist Endoscopic Instrument FamilySummary page 2…tive Surgical da Vinci ¢ Surgical System and Endoscopic Devices Instruments (legally marketed underK990144, K002489, KO1 1002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802 and… | 2002 |
| * | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000Summary page 2…ical da Vinci ¢ Surgical System and Endoscopic Devices Instruments (legally marketed underK990144, K002489, KO1 1002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802 and K063220)… | 2002 |
| * | K022574 | Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…Summary page 2…Endoscopic Devices Instruments (legally marketed underK990144, K002489, KO1 1002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802 and K063220) Intuitive… | 2002 |
| * | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…Summary page 2…c Devices Instruments (legally marketed underK990144, K002489, KO1 1002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802 and K063220) Intuitive Surgical… | 2004 |
| Kept off the family tree | K043153 | FDA’s K043153 is Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
| * | K043288 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsSummary page 2…Instruments (legally marketed underK990144, K002489, KO1 1002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802 and K063220) Intuitive Surgical Endo Wrist® Long… | 2005 |
| * | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsSummary page 2…Instruments (legally marketed underK990144, K002489, KO1 1002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802 and K063220) Intuitive Surgical Endo Wrist® Long Tip Forc… | 2005 |
| * | K050369 | Intuitive Surgical DA Vinci Surgical System, Model IS2000Summary page 2…ts (legally marketed underK990144, K002489, KO1 1002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802 and K063220) Intuitive Surgical Endo Wrist® Long Tip Forceps and E… | 2005 |
| * | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsSummary page 2…(legally marketed underK990144, K002489, KO1 1002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802 and K063220) Intuitive Surgical Endo Wrist® Long Tip Forceps and Endo Wrist… | 2005 |
| * | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000Summary page 2…nderK990144, K002489, KO1 1002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802 and K063220) Intuitive Surgical Endo Wrist® Long Tip Forceps and Endo Wrist Pericardial Dis… | 2006 |
| * | K062140 | Surgifrost XL Cryosurgical Device, Model 60SFXL; Cryosurgical Console, Model 65CS1Summary page 2…990144, K013416, K021036, and K050369) CryoCath Inc. SurgiFrost® Surgical CryoAblation System (legally marketed under K062140, K053436 and K040690) Device This special 510(k) is being submitted for an additional Description E… | 2006 |
| * | K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical…Summary page 2…013416, K021036, and K050369) CryoCath Inc. SurgiFrost® Surgical CryoAblation System (legally marketed under K062140, K053436 and K040690) Device This special 510(k) is being submitted for an additional Description EndoWrist®… | 2006 |
| * | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleSummary page 2…036, and K050369) CryoCath Inc. SurgiFrost® Surgical CryoAblation System (legally marketed under K062140, K053436 and K040690) Device This special 510(k) is being submitted for an additional Description EndoWrist®instrument,… | 2004 |
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 |
|---|---|---|---|---|
| Apr 18, 2008 | Not classified | Z-1811-2008 | Software design | The product has a software interface problem. When the product is connected to the da Vinci IS2000 System it will not allow the System to recognize the Instrument which makes the IS2000 CPG instrument nonfunctional at all sites. Risks… |
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 1.4 years on median.
- 10 of the 80 ancestors have a recall of any class.
- 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. 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, 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 (146 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 and cryogenic ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, general cardiovascular and 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. The system is indicated for adult and pediatric use. 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/K070947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070947: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist Cardiac Probe Grasper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070947
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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