510(k) Report

510(k) · Cleared

Cleared

Intuitive Surgical DA Vinci and DA Vinci S Surgical System and Endoscopic Instruments and Endowrist Introducer

K072627510(k) TraditionalCleared Feb 7, 2008143-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Intuitive Surgical, Inc. · NAY System, Surgical, Computer Controlled Instrument

Cleared on Feb 7, 2008 as substantially equivalent to K990144 (Intuitive Surgical, Inc., 2000) and 11 other predicates after a 143-day review. Its family tree reaches back 10 generations to 1994.

Decided
Feb 7, 2008
Review
143 days
Class
Class II
Product code
NAY
Recalls
None
Predicates
13

Its longest line of descent runs back 10 generations to K930667 (1994). 44 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 2 other ancestors2002: 3 other ancestors2001: 5 other ancestors2004: 3 other ancestors1997: 6 other ancestors1993: 2 other ancestors1999: 2 other ancestors1995: 2 other ancestors1994: 2 other ancestors1992: 1 other ancestor1998: 2 other ancestors1991: 2 other ancestors1988: 1 other ancestor1981: 1 other ancestorReference device: K024206 · Aura Isurgical Laser System & Accessories · Laserscope · 2003Reference device: K051167 · Revolix and Revolix JR · Allmed Systems, Inc. · 2005K930667 · Reusable Laparoscopic Instruments · Snowden-Pencer · 1994 · recalledK960400 · Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts) · Snowden-Pencer · 1996K990144 · Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System · Intuitive Surgical, Inc. · 2000 · recalledK021036 · Intuitive Surgical DA Vinci Surgical System, Model IS1000 · Intuitive Surgical, Inc. · 2002 · recalledK040237 · Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2004×4: 4 generations cleared close together, K043153 (2004), K050005 (2005), K050404 (2005), K050802 (2005) K063220 · DA Vinci S Surgical System-V1.1, Model IS2000 · Intuitive Surgical, Inc. · 2006 · recalled1980198519901995200020052010
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 6 other ancestors3 generations back: 8 other ancestors4 generations back: 6 other ancestors5 generations back: 5 other ancestors6 generations back: 3 other ancestors K063220 · DA Vinci S Surgical System-V1.1, Model IS2000 · Intuitive Surgical, Inc. · 2006 · recalledK050802 · Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2005K050404 · Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2005K050005 · Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model 400180 · Intuitive Surgical, Inc. · 2005 · recalledK043153 · Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000 · Intuitive Surgical, Inc. · 2004K040237 · Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2004K021036 · Intuitive Surgical DA Vinci Surgical System, Model IS1000 · Intuitive Surgical, Inc. · 2002 · recalledK990144 · Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System · Intuitive Surgical, Inc. · 2000 · recalledK960400 · Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts) · Snowden-Pencer · 1996K930667 · Reusable Laparoscopic Instruments · Snowden-Pencer · 1994 · recalled−10−50
  1. Root · 10 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 6 generations between
  3. 3 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
  4. 2 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
  5. 1 generation backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
  6. This deviceK072627 Intuitive Surgical DA Vinci and DA Vinci S Surgical System and…Intuitive Surgical, Inc. · 2008
Show all 10 generations
  1. Root · 10 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 9 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
  3. 8 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
  4. 7 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
  5. 6 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
  6. 5 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
  7. 4 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
  8. 3 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
  9. 2 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
  10. 1 generation backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
  11. This deviceK072627 Intuitive Surgical DA Vinci and DA Vinci S Surgical System and…Intuitive Surgical, Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K930667Reusable Laparoscopic InstrumentsSnowden-Pencer199415
−9K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer1996—
−8K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic…Intuitive Surgical, Inc.20003
−7K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc.200218
−6K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc.2004—
−5K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models…Intuitive Surgical, Inc.2004—
−4K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover…Intuitive Surgical, Inc.20052
−3K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005—
−2K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc.2005—
−1K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc.20064
0 (this device)K072627Intuitive Surgical DA Vinci and DA Vinci S Surgical System and Endoscopic…Intuitive Surgical, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198810
199120
199210
199320
199420
199520
199760
199820
199920
200150
200230
200430
200520
FIG. 1 — Lineage of K072627, 1994–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K232610 da Vinci Surgical System Model IS5000, da…score 32.9 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (13)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…
Summary page 2
…Intuitive Surgical da Vinci® and da Vinci® S 'M Surgical System and Devices Endoscopic Instruments (legally marketed under K990144, K002489, K011002, K013416, K021036, K022574, K040237, K43153, K043288, K05…
Intuitive Surgical, Inc.20003
*K002489Intuitive Surgical DA Vinci Endoscopic Control System
Summary page 2
…tive Surgical da Vinci® and da Vinci® S 'M Surgical System and Devices Endoscopic Instruments (legally marketed under K990144, K002489, K011002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K05…
Intuitive Surgical, Inc.2001—
*K011002Intuitive Surgical DA Vinci Surgical System, Model Isi 1000
Summary page 2
…ical da Vinci® and da Vinci® S 'M Surgical System and Devices Endoscopic Instruments (legally marketed under K990144, K002489, K011002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K05…
Intuitive Surgical, Inc.2001—
*K013416Intuitive Surgical Endowrist Endoscopic Instrument Family
Summary page 2
…rgical System and Devices Endoscopic Instruments (legally marketed under K990144, K002489, K011002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802 and K063220)…
Intuitive Surgical, Inc.2002—
*K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000
Summary page 2
…stem and Devices Endoscopic Instruments (legally marketed under K990144, K002489, K011002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802 and K063220) I…
Intuitive Surgical, Inc.200218
*K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…
Summary page 2
…Devices Endoscopic Instruments (legally marketed under K990144, K002489, K011002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802 and K063220) Intuitive…
Intuitive Surgical, Inc.2002—
*K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…
Summary page 2
…Endoscopic Instruments (legally marketed under K990144, K002489, K011002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802 and K063220) Intuitive Surgical…
Intuitive Surgical, Inc.2004—
Kept off the family treeK043153FDA’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
Intuitive Surgical, Inc.2004—
*K043288Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments
Summary page 2
…doscopic Instruments (legally marketed under K990144, K002489, K011002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802 and K063220) Intuitive Surgical Endo Wrist® Monop…
Intuitive Surgical, Inc.2005—
*K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments
Summary page 2
…(legally marketed under K990144, K002489, K011002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802 and K063220) Intuitive Surgical Endo Wrist® Monopolar Cautery Instrument…
Intuitive Surgical, Inc.2005—
*K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000
Summary page 2
…(legally marketed under K990144, K002489, K011002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802 and K063220) Intuitive Surgical Endo Wrist® Monopolar Cautery Instrument…
Intuitive Surgical, Inc.200551
*K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments
Summary page 2
…ly marketed under K990144, K002489, K011002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802 and K063220) Intuitive Surgical Endo Wrist® Monopolar Cautery Instrument (l…
Intuitive Surgical, Inc.2005—
*K063220DA Vinci S Surgical System-V1.1, Model IS2000
Summary page 2
…under K990144, K002489, K011002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802 and K063220) Intuitive Surgical Endo Wrist® Monopolar Cautery Instrument (legally marke…
Intuitive Surgical, Inc.20064
†K024206Aura Isurgical Laser System & AccessoriesLaserscope2003—
†K051167Revolix and Revolix JRAllmed Systems, Inc.2005—

Also cleared against K990144: 20 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

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.
  • 7 of the 44 ancestors have a recall of any class.
  • 20 other devices also cite its predicate K990144.

How does its category compare?

All NAY devices

NAY 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

2008: 42009: 32010: 12011: 72012: 42013: 42014: 92015: 32016: 82017: 162018: 152019: 82020: 92021: 112022: 62023: 52024: 102025: 162026 (partial year): 7
2007high 16 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NAY

117in 2025

2008: 189 days median2009: 253 days median2011: 191 days median2012: 106 days median2013: 144 days median2014: 143 days median2015: 99 days median2016: 197 days median2017: 107 days median2018: 152 days median2019: 73 days median2020: 212 days median2021: 61 days median2022: 57 days median2023: 141 days median2024: 126 days median2025: 117 days median2026 (partial year): 89 days median
2007high 253 (2009) · low 57 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NAY

1in 2025

2007: 112008: 32009: 12011: 22012: 12013: 62014: 252015: 32016: 12017: 12018: 22019: 52021: 32022: 32023: 2, 1 Class I2024: 402025: 12026 (partial year): 4, 1 Class I
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

2007: 1332008: 2242009: 3802010: 6232011: 5012012: 1,5522013: 6,2172014: 6,1352015: 1,7222016: 1,0772017: 1,0492018: 1,0742019: 1,1542020: 1,5582021: 1,9972022: 5,7272023: 10,8982024: 12,8722025: 48,456
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—11133
200841893224
200932531380
20101—0623
201171912501
2012410611,552
2013414466,217
20149143256,135
201539931,722
2016819711,077
20171610711,049
20181515221,074
201987351,154
2020921201,558
2021116131,997
202265735,727
202351412 (1)10,898
2024101264012,872
202516117148,456
20267894 (1)—

What is it indicated for?

The Intuitive Surgical Endo Wrist Introducer, 5Fr is intended to be used as a conduit through which compatible surgical laser fibers may be held and directed in conjunction with da Vinci and da Vinci S surgical systems. At this time, only the following surgical laser systems are compatible for use with the da Vinci and da Vinci S systems: Lisa Laser Revolix Jr. and Laserscope Aura -XP systems. It may also be used to perform blunt dissection when the laser fiber is retracted or not within the instrument.

Indications for use as stated in the FDA summary.

Also cleared against K990144

20 other devices cite the same predicate.

  • K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc. · 2014
  • K1017435MM Flared Cannula Model 420262, 8MM Flared Cannula Model 420319Intuitive Surgical, Inc. · 20111 recall
  • K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc. · 20093 recalls
  • K070947Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist Cardiac Probe GrasperIntuitive Surgical, Inc. · 20081 recall
  • K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc. · 20061 recall
  • K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 20061 recall

More from Intuitive Surgical, Inc.

181 FDA decisions under this applicant name. See the company

  • K262455da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci…Intuitive Surgical, Inc. · 2026
  • K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc. · 2026
  • K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K261249Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2026

Recent decisions in NAY

The NAY category page

  • K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K260695da Vinci Firefly Imaging SystemIntuitive Surgical · 2026
  • K254192Senhance Ultrasonic SystemAsensus Surgical · 2026
  • K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc. · 2026

https://510kreport.com/device/K072627 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072627: Intuitive Surgical DA Vinci and DA Vinci S Surgical System and Endoscopic Instruments and Endowrist Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072627

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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