510(k) Report

510(k) · Cleared

Cleared

Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments

K050802510(k) TraditionalCleared Jun 29, 200591-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 Jun 29, 2005 as substantially equivalent to K990144 (Intuitive Surgical, Inc., 2000) and 13 other predicates after a 91-day review. Its family tree reaches back 8 generations to 1994. 1 of the 271 devices in its family, counting itself, has a Class I recall. 228 later devices descend from it.

Decided
Jun 29, 2005
Review
91 days
Class
Class II
Product code
NAY
Recalls
None
Predicates
14

Its longest line of descent runs back 8 generations to K930667 (1994). 42 ancestors in all, the oldest K811390 (1981). 228 later devices descend from it, 7 citing it directly. 1 of the 271 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2005: 2 other ancestors2004: 3 other ancestors2002: 3 other ancestors2001: 5 other ancestors1999: 2 other ancestors1997: 6 other ancestors1993: 2 other ancestors1998: 2 other ancestors1995: 2 other ancestors1994: 2 other ancestors1992: 1 other ancestor1991: 2 other ancestors1988: 1 other ancestor1981: 1 other ancestor2006: 3 descendants cleared2009: 2 descendants cleared2008: 5 descendants cleared2014: 9 descendants cleared2017: 14 descendants cleared2012: 4 descendants cleared2019: 9 descendants cleared2018: 16 descendants cleared2016: 9 descendants cleared2020: 17 descendants cleared2021: 16 descendants cleared2022: 18 descendants cleared2011: 4 descendants cleared2025: 31 descendants cleared2024: 22 descendants cleared2013: 4 descendants cleared2015: 4 descendants cleared2026: 22 descendants cleared2023: 19 descendants cleared, 1 with a Class I recall1K930667 · 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×4: 4 generations cleared close together, K040237 (2004), K043153 (2004), K050005 (2005), K050404 (2005) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 7 other ancestors3 generations back: 9 other ancestors4 generations back: 6 other ancestors5 generations back: 4 other ancestors 1 generation forward: 7 descendants2 generations forward: 25 descendants3 generations forward: 36 descendants, 1 with a Class I recall14 generations forward: 30 descendants5 generations forward: 23 descendants6 generations forward: 31 descendants7 generations forward: 27 descendants8 generations forward: 21 descendants9 generations forward: 18 descendants10 generations forward: 8 descendants11 generations forward: 2 descendants K050404 · 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−50+5+10
  1. Root · 8 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 7 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
  3. 6 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
  4. 5 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
  5. 4 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
  6. 3 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
  7. 2 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
  8. 1 generation backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
  9. This deviceK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
  10. Descendant · cites it directly · 224 of its ownK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
  11. Descendant · 2 generations on · 211 of its ownK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
  12. Descendant · cites it directly · 155 of its ownK060391 Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 2006 · Recalled
  13. Descendant · cites it directly · 154 of its ownK061260 Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 &…Intuitive Surgical, Inc. · 2006 · Recalled
  14. Descendant · cites it directly · 153 of its ownK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled

Showing 5 of 228 descendants. See all descendants

Descendants cleared per year

2006: 32008: 52009: 22011: 42012: 42013: 42014: 92015: 42016: 92017: 142018: 162019: 92020: 172021: 162022: 182023: 192024: 222025: 312026: 22
2006high 31 (2025) · low 0 (2007)2026

Class I recalls in this family

  • K223095 Senhance Surgical System3 generations on · 2023

Most influential descendants

Showing 5 of 228 · See all
  • K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · cites it directly224descendants
  • K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · 2 generations on211descendants
  • K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 2006 · cites it directly155descendants
  • K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc. · 2006 · cites it directly154descendants
  • K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc. · 2009 · cites it directly153descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K930667Reusable Laparoscopic InstrumentsSnowden-Pencer199415
−7K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer1996—
−6K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic…Intuitive Surgical, Inc.20003
−5K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc.200218
−4K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc.2004—
−3K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models…Intuitive Surgical, Inc.2004—
−2K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover…Intuitive Surgical, Inc.20052
−1K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005—
0 (this device)K050802Modification 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
+2K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc.200925
+1K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc.20061
+1K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc.20061
+1K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200…Intuitive Surgical, Inc.20093

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200630
200850
200920
201140
201240
201340
201490
201540
201690
2017140
2018160
201990
2020170
2021160
2022180
2023191
2024220
2025310
2026220
FIG. 1 — Lineage of K050802, 1994–2026Source: 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.

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. #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? (14)

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 1
…uments and Accessories Predicate Intuitive Surgical da Vinci Surgical System and Endoscopic Instruments Devices (legally marketed under K990144 / K002489 K011002 / K012833 / K013416 / K021036 / K022574 / K040237 K040948 / K043153 /…
Intuitive Surgical, Inc.20003
*K002489Intuitive Surgical DA Vinci Endoscopic Control System
Summary page 1
…Accessories Predicate Intuitive Surgical da Vinci Surgical System and Endoscopic Instruments Devices (legally marketed under K990144 / K002489 K011002 / K012833 / K013416 / K021036 / K022574 / K040237 K040948 / K043153 / K…
Intuitive Surgical, Inc.2001—
*K011002Intuitive Surgical DA Vinci Surgical System, Model Isi 1000
Summary page 1
…ries Predicate Intuitive Surgical da Vinci Surgical System and Endoscopic Instruments Devices (legally marketed under K990144 / K002489 K011002 / K012833 / K013416 / K021036 / K022574 / K040237 K040948 / K043153 / K043288 /…
Intuitive Surgical, Inc.2001—
*K012833Intuitive Surgical Bipolar Forceps
Summary page 1
…dicate Intuitive Surgical da Vinci Surgical System and Endoscopic Instruments Devices (legally marketed under K990144 / K002489 K011002 / K012833 / K013416 / K021036 / K022574 / K040237 K040948 / K043153 / K043288 / K050005 /…
Intuitive Surgical, Inc.20014
*K013416Intuitive Surgical Endowrist Endoscopic Instrument Family
Summary page 1
…gical da Vinci Surgical System and Endoscopic Instruments Devices (legally marketed under K990144 / K002489 K011002 / K012833 / K013416 / K021036 / K022574 / K040237 K040948 / K043153 / K043288 / K050005 / K050369 / K050404). Device…
Intuitive Surgical, Inc.2002—
*K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000
Summary page 1
…inci Surgical System and Endoscopic Instruments Devices (legally marketed under K990144 / K002489 K011002 / K012833 / K013416 / K021036 / K022574 / K040237 K040948 / K043153 / K043288 / K050005 / K050369 / K050404). Device…
Intuitive Surgical, Inc.200218
*K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…
Summary page 1
…cal System and Endoscopic Instruments Devices (legally marketed under K990144 / K002489 K011002 / K012833 / K013416 / K021036 / K022574 / K040237 K040948 / K043153 / K043288 / K050005 / K050369 / K050404). Device This 510…
Intuitive Surgical, Inc.2002—
*K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…
Summary page 1
…and Endoscopic Instruments Devices (legally marketed under K990144 / K002489 K011002 / K012833 / K013416 / K021036 / K022574 / K040237 K040948 / K043153 / K043288 / K050005 / K050369 / K050404). Device This 510(k) is bei…
Intuitive Surgical, Inc.2004—
*K040948Intuitive Surgical Endopass Endoscopic Delivery Instrument, Model P/N 400170
Summary page 1
…oscopic Instruments Devices (legally marketed under K990144 / K002489 K011002 / K012833 / K013416 / K021036 / K022574 / K040237 K040948 / K043153 / K043288 / K050005 / K050369 / K050404). Device This 510(k) is being submi…
Intuitive Surgical, Inc.2004—
*K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…
Summary page 1
…struments Devices (legally marketed under K990144 / K002489 K011002 / K012833 / K013416 / K021036 / K022574 / K040237 K040948 / K043153 / K043288 / K050005 / K050369 / K050404). Device This 510(k) is being submitted for a…
Intuitive Surgical, Inc.2004—
*K043288Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments
Summary page 1
…(legally marketed under K990144 / K002489 K011002 / K012833 / K013416 / K021036 / K022574 / K040237 K040948 / K043153 / K043288 / K050005 / K050369 / K050404). Device This 510(k) is being submitted for an expansion of the Indications for…
Intuitive Surgical, Inc.2005—
*K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…
Summary page 1
…arketed under K990144 / K002489 K011002 / K012833 / K013416 / K021036 / K022574 / K040237 K040948 / K043153 / K043288 / K050005 / K050369 / K050404). Device This 510(k) is being submitted for an expansion of the Indications for Descriptio…
Intuitive Surgical, Inc.20052
*K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000
Cleared while this submission was under review
Summary page 1
…der K990144 / K002489 K011002 / K012833 / K013416 / K021036 / K022574 / K040237 K040948 / K043153 / K043288 / K050005 / K050369 / K050404). Device This 510(k) is being submitted for an expansion of the Indications for Description…
Intuitive Surgical, Inc.200551
*K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments
Cleared while this submission was under review
Summary page 1
…4 / K002489 K011002 / K012833 / K013416 / K021036 / K022574 / K040237 K040948 / K043153 / K043288 / K050005 / K050369 / K050404). Device This 510(k) is being submitted for an expansion of the Indications for Description Use t…
Intuitive Surgical, Inc.2005—

Also cleared against K990144: 20 other devices →

What descends from it? (228)

See all 228

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

NumberDeviceApplicantDecidedDescendants
K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc.2006224
K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc.2006155
K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc.2006154
K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc.2009153
K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc.20143
K070947Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist…Intuitive Surgical, Inc.20080
K072627Intuitive Surgical DA Vinci and DA Vinci S Surgical System and Endoscopic Instruments…Intuitive Surgical, Inc.20080

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

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 1.8 years on median.
  • 6 of the 42 ancestors have a recall of any class.
  • Of its descendants, K063220 (Intuitive Surgical, Inc., 2006) has gone furthest, with 224 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.

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® da Vinci® Surgical 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 (142 words)

The Intuitive Surgical® da Vinci® Surgical 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 urologic surgical procedures, general laparoscopic surgical procedures, gynecologic 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. 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.

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
  • 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

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/K050802 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050802: Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050802

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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