510(k) Report

510(k) · Decided

Decided

DA Vinvi Surgical System

K123329510(k) TraditionalDecided Sep 17, 2014691-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 Sep 17, 2014 as substantially equivalent to K990144 (Intuitive Surgical, Inc., 2000) and 28 other predicates after a 691-day review. Its family tree reaches back 13 generations to 1994. 3 later devices descend from it.

Decided
Sep 17, 2014
Review
691 days
Class
Class II
Product code
NAY
Recalls
None
Predicates
29

Its longest line of descent runs back 13 generations to K930667 (1994). 80 ancestors in all, the oldest K811390 (1981). 3 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 5 other ancestors2010: 1 other ancestor2006: 4 other ancestors2005: 2 other ancestors2004: 5 other ancestors2002: 4 other ancestors2001: 5 other ancestors2008: 1 other ancestor2007: 1 other ancestor2003: 2 other ancestors1999: 4 other ancestors1997: 7 other ancestors1993: 2 other ancestors2000: 1 other ancestor1998: 3 other ancestors1996: 2 other ancestors1995: 6 other ancestors1994: 6 other ancestors1992: 1 other ancestor1991: 3 other ancestors1988: 1 other ancestor1981: 1 other ancestor2018: 1 descendant cleared2017: 1 descendant cleared2022: 1 descendant clearedK930667 · 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 · recalled×5: 5 generations cleared close together, K040237 (2004), K043153 (2004), K050005 (2005), K050404 (2005), K050802 (2005) K063220 · DA Vinci S Surgical System-V1.1, Model IS2000 · Intuitive Surgical, Inc. · 2006 · recalledK081137 · Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 · Intuitive Surgical, Inc. · 2009 · recalledK090993 · Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000 · Intuitive Surgical, Inc. · 2009 · recalledK112263 · Monopolar Curved Scissors Tip Cover Accessory · Intuitive Surgical, Inc. · 2011 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 18 other ancestors2 generations back: 12 other ancestors3 generations back: 20 other ancestors4 generations back: 7 other ancestors5 generations back: 10 other ancestors 1 generation forward: 3 descendants K112263 · Monopolar Curved Scissors Tip Cover Accessory · Intuitive Surgical, Inc. · 2011 · recalledK090993 · Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000 · Intuitive Surgical, Inc. · 2009 · recalledK081137 · Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 · Intuitive Surgical, Inc. · 2009 · recalledK063220 · 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 · 13 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 9 generations between
  3. 3 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
  4. 2 generations backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
  5. 1 generation backK112263 Monopolar Curved Scissors Tip Cover AccessoryIntuitive Surgical, Inc. · 2011 · Recalled
  6. This deviceK123329 DA Vinvi Surgical SystemIntuitive Surgical, Inc. · 2014
  7. Descendant · cites it directly · 0 of its ownK210478 8mm Monopolar Curved ScissorsIconocare Health · 2022
  8. Descendant · cites it directly · 0 of its ownK173415 EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc. · 2018
  9. Descendant · cites it directly · 0 of its ownK170641 da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc. · 2017
Show all 13 generations
  1. Root · 13 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 12 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
  3. 11 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
  4. 10 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
  5. 9 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
  6. 8 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
  7. 7 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
  8. 6 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
  9. 5 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
  10. 4 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
  11. 3 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
  12. 2 generations backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
  13. 1 generation backK112263 Monopolar Curved Scissors Tip Cover AccessoryIntuitive Surgical, Inc. · 2011 · Recalled
  14. This deviceK123329 DA Vinvi Surgical SystemIntuitive Surgical, Inc. · 2014

Most influential descendants

Showing 3 of 3 · See all
  • K2104788mm Monopolar Curved ScissorsIconocare Health · 2022 · cites it directly0descendants
  • K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc. · 2018 · cites it directly0descendants
  • K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K930667Reusable Laparoscopic InstrumentsSnowden-Pencer199415
−12K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer1996—
−11K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic…Intuitive Surgical, Inc.20003
−10K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc.200218
−9K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc.2004—
−8K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models…Intuitive Surgical, Inc.2004—
−7K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover…Intuitive Surgical, Inc.20052
−6K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005—
−5K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc.2005—
−4K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc.20064
−3K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc.200925
−2K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200…Intuitive Surgical, Inc.20093
−1K112263Monopolar Curved Scissors Tip Cover AccessoryIntuitive Surgical, Inc.20111
0 (this device)K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc.2014—
+1K2104788mm Monopolar Curved ScissorsIconocare Health2022—
+1K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc.2018—
+1K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198810
199130
199210
199320
199460
199560
199620
199770
199830
199940
200010
200150
200240
200320
200450
200520
200640
200710
200810
201010
201150

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
202210
FIG. 1 — Lineage of K123329, 1994–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (29)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…
Summary page 4
…Systems (Models IS1200, IS2000, IS3000) and EndoWrist Instruments and Accessories legally marketed under: K990144, K002489, K011002, K011281, K012833, K013416, K021036, K022574, K…
Intuitive Surgical, Inc.20003
*K002489Intuitive Surgical DA Vinci Endoscopic Control System
Summary page 4
…IS1200, IS2000, IS3000) and EndoWrist Instruments and Accessories legally marketed under: K990144, K002489, K011002, K011281, K012833, K013416, K021036, K022574, K040237, K040948, K042855,…
Intuitive Surgical, Inc.2001—
*K011002Intuitive Surgical DA Vinci Surgical System, Model Isi 1000
Summary page 4
…1200, IS2000, IS3000) and EndoWrist Instruments and Accessories legally marketed under: K990144, K002489, K011002, K011281, K012833, K013416, K021036, K022574, K040237, K040948, K042855,…
Intuitive Surgical, Inc.2001—
*K011281Intuitive Surgical Ultrasonic Shears
Summary page 4
…000, IS3000) and EndoWrist Instruments and Accessories legally marketed under: K990144, K002489, K011002, K011281, K012833, K013416, K021036, K022574, K040237, K040948, K042855, K…
Intuitive Surgical, Inc.2001—
*K012833Intuitive Surgical Bipolar Forceps
Summary page 4
…00) and EndoWrist Instruments and Accessories legally marketed under: K990144, K002489, K011002, K011281, K012833, K013416, K021036, K022574, K040237, K040948, K042855, K043153, K…
Intuitive Surgical, Inc.20014
*K013416Intuitive Surgical Endowrist Endoscopic Instrument Family
Summary page 4
…ndoWrist Instruments and Accessories legally marketed under: K990144, K002489, K011002, K011281, K012833, K013416, K021036, K022574, K040237, K040948, K042855, K043153, K043288, K…
Intuitive Surgical, Inc.2002—
*K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000
Summary page 4
…and Accessories legally marketed under: K990144, K002489, K011002, K011281, K012833, K013416, K021036, K022574, K040237, K040948, K042855, K043153, K043288, K050005, K050369, K050404,…
Intuitive Surgical, Inc.200218
*K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…
Summary page 4
…and Accessories legally marketed under: K990144, K002489, K011002, K011281, K012833, K013416, K021036, K022574, K040237, K040948, K042855, K043153, K043288, K050005, K050369, K050404,…
Intuitive Surgical, Inc.2002—
*K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…
Summary page 4
…cessories legally marketed under: K990144, K002489, K011002, K011281, K012833, K013416, K021036, K022574, K040237, K040948, K042855, K043153, K043288, K050005, K050369, K050404, K…
Intuitive Surgical, Inc.2004—
*K040948Intuitive Surgical Endopass Endoscopic Delivery Instrument, Model P/N 400170
Summary page 4
…legally marketed under: K990144, K002489, K011002, K011281, K012833, K013416, K021036, K022574, K040237, K040948, K042855, K043153, K043288, K050005, K050369, K050404, K050802, K…
Intuitive Surgical, Inc.2004—
*K042855Intuitive Surgical Harmonic Curved Shears Instrument
Summary page 4
…marketed under: K990144, K002489, K011002, K011281, K012833, K013416, K021036, K022574, K040237, K040948, K042855, K043153, K043288, K050005, K050369, K050404, K050802, K060391, K…
Intuitive Surgical, Inc.2004—
*K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…
Summary page 4
…K002489, K011002, K011281, K012833, K013416, K021036, K022574, K040237, K040948, K042855, K043153, K043288, K050005, K050369, K050404, K050802, K060391, K061260, K063220, K081137,…
Intuitive Surgical, Inc.2004—
*K043288Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments
Summary page 4
…K002489, K011002, K011281, K012833, K013416, K021036, K022574, K040237, K040948, K042855, K043153, K043288, K050005, K050369, K050404, K050802, K060391, K061260, K063220, K081137,…
Intuitive Surgical, Inc.2005—
*K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…
Summary page 4
…02489, K011002, K011281, K012833, K013416, K021036, K022574, K040237, K040948, K042855, K043153, K043288, K050005, K050369, K050404, K050802, K060391, K061260, K063220, K081137, K…
Intuitive Surgical, Inc.20052
*K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000
Summary page 4
…11002, K011281, K012833, K013416, K021036, K022574, K040237, K040948, K042855, K043153, K043288, K050005, K050369, K050404, K050802, K060391, K061260, K063220, K081137, K090993, K…
Intuitive Surgical, Inc.200551
*K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments
Summary page 4
…11281, K012833, K013416, K021036, K022574, K040237, K040948, K042855, K043153, K043288, K050005, K050369, K050404, K050802, K060391, K061260, K063220, K081137, K090993, K093217, K…
Intuitive Surgical, Inc.2005—
*K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments
Summary page 4
…K021036, K022574, K040237, K040948, K042855, K043153, K043288, K050005, K050369, K050404, K050802, K060391, K061260, K063220, K081137, K090993, K093217, K101743, K101581, K110451,…
Intuitive Surgical, Inc.2005—
*K060391Intuitive Surgical Endowrist Stabilizer, Model 420182
Summary page 4
…K021036, K022574, K040237, K040948, K042855, K043153, K043288, K050005, K050369, K050404, K050802, K060391, K061260, K063220, K081137, K090993, K093217, K101743, K101581, K110451,…
Intuitive Surgical, Inc.20061
*K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214
Summary page 4
…21036, K022574, K040237, K040948, K042855, K043153, K043288, K050005, K050369, K050404, K050802, K060391, K061260, K063220, K081137, K090993, K093217, K101743, K101581, K110451, K…
Intuitive Surgical, Inc.20061
*K063220DA Vinci S Surgical System-V1.1, Model IS2000
Summary page 4
…22574, K040237, K040948, K042855, K043153, K043288, K050005, K050369, K050404, K050802, K060391, K061260, K063220, K081137, K090993, K093217, K101743, K101581, K110451, K112584, K…
Intuitive Surgical, Inc.20064
*K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000
Summary page 4
…40237, K040948, K042855, K043153, K043288, K050005, K050369, K050404, K050802, K060391, K061260, K063220, K081137, K090993, K093217, K101743, K101581, K110451, K112584, K112263, a…
Intuitive Surgical, Inc.200925
*K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000
Summary page 4
…K043153, K043288, K050005, K050369, K050404, K050802, K060391, K061260, K063220, K081137, K090993, K093217, K101743, K101581, K110451, K112584, K112263, and K110639 Device Description: This 510(…
Intuitive Surgical, Inc.20093
*K0932175 MM Harmonic Ace Instrument (Used with DA Vinci IS1200 & IS2000/IS3000 System)
Summary page 4
…K043153, K043288, K050005, K050369, K050404, K050802, K060391, K061260, K063220, K081137, K090993, K093217, K101743, K101581, K110451, K112584, K112263, and K110639 Device Description: This 510(k) is bei…
Intuitive Surgical, Inc.20103
*K1017435MM Flared Cannula Model 420262, 8MM Flared Cannula Model 420319
Summary page 4
…43153, K043288, K050005, K050369, K050404, K050802, K060391, K061260, K063220, K081137, K090993, K093217, K101743, K101581, K110451, K112584, K112263, and K110639 Device Description: This 510(k) is being submit…
Intuitive Surgical, Inc.20111
*K101581Intuitive Surgical DA Vinci S Surgical System with DA Vinci Connect & DA Vinci Onsite…
Summary page 4
…43288, K050005, K050369, K050404, K050802, K060391, K061260, K063220, K081137, K090993, K093217, K101743, K101581, K110451, K112584, K112263, and K110639 Device Description: This 510(k) is being submitted for a…
Intuitive Surgical, Inc.2011—
*K110451Endowrist One Suction/Irrigator
Summary page 4
…50005, K050369, K050404, K050802, K060391, K061260, K063220, K081137, K090993, K093217, K101743, K101581, K110451, K112584, K112263, and K110639 Device Description: This 510(k) is being submitted for a revision…
Intuitive Surgical, Inc.2011—
*K1125845MM/8MM Harmonic Ace (TM) Curved Shears, Disposable Harmonic Ace (TM) Insert, Disposable…
Summary page 4
…K050802, K060391, K061260, K063220, K081137, K090993, K093217, K101743, K101581, K110451, K112584, K112263, and K110639 Device Description: This 510(k) is being submitted for a revision to the Indications for Use to include Tr…
Intuitive Surgical, Inc.20111
*K112263Monopolar Curved Scissors Tip Cover Accessory
Summary page 4
…K050802, K060391, K061260, K063220, K081137, K090993, K093217, K101743, K101581, K110451, K112584, K112263, and K110639 Device Description: This 510(k) is being submitted for a revision to the Indications for Use to include Transoral O…
Intuitive Surgical, Inc.20111
*K110639Endowrist One Vessel Sealer
Summary page 4
…2, K060391, K061260, K063220, K081137, K090993, K093217, K101743, K101581, K110451, K112584, K112263, and K110639 Device Description: This 510(k) is being submitted for a revision to the Indications for Use to include Transoral Otolaryngology…
Intuitive Surgical, Inc.20112

Also cleared against K990144: 20 other devices →

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K2104788mm Monopolar Curved ScissorsIconocare Health20220
K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc.20180
K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc.20170

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 20 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
  • 20 of the 80 ancestors have a recall of any class.
  • Of its descendants, K210478 (Iconocare Health, 2022) has gone furthest, with 0 descendants of its own.
  • 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. 2014, 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?

Transoral otolaryngology surgical procedures restricted to benign and malignant tumors, classified as T1 and T2, and for

benign base of tongue resection procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K990144

20 other devices cite the same predicate.

  • 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
  • K072627Intuitive Surgical DA Vinci and DA Vinci S Surgical System and Endoscopic Instruments and Endowrist IntroducerIntuitive Surgical, Inc. · 2008
  • 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/K123329 · printed Nov 5, 2026

Cite this page

510(k) Report. “K123329: DA Vinvi Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123329

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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