510(k) Report

510(k) · Cleared

Cleared

Intuitive Surgical Endowrist Endoscopic Instrument Family

K013416510(k) TraditionalCleared Jan 10, 200287-day reviewClass II21 CFR 878.4400

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

Intuitive Surgical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jan 10, 2002 as substantially equivalent to K965001 (Intuitive Surgical, Inc., 1997) and 3 other predicates after an 87-day review. Its family tree reaches back 3 generations to 1994. 1 of the 266 devices in its family, counting itself, has a Class I recall. 254 later devices descend from it.

Decided
Jan 10, 2002
Review
87 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K930667 (1994). 11 ancestors in all, the oldest K914190 (1992). 254 later devices descend from it, 11 citing it directly. 1 of the 266 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors1997: 1 other ancestor1995: 1 other ancestor1994: 2 other ancestors1993: 1 other ancestor1992: 1 other ancestor2004: 2 descendants cleared2009: 3 descendants cleared2008: 6 descendants cleared2005: 5 descendants cleared2014: 11 descendants cleared2011: 5 descendants cleared2006: 3 descendants cleared2018: 18 descendants cleared2025: 31 descendants cleared2024: 22 descendants cleared2017: 15 descendants cleared2022: 18 descendants cleared2013: 6 descendants cleared2012: 4 descendants cleared2019: 11 descendants cleared2016: 11 descendants cleared2020: 19 descendants cleared2021: 17 descendants cleared2015: 5 descendants cleared2026: 23 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 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors3 generations back: 1 other ancestor 1 generation forward: 11 descendants2 generations forward: 37 descendants3 generations forward: 37 descendants, 1 with a Class I recall14 generations forward: 30 descendants5 generations forward: 25 descendants6 generations forward: 33 descendants7 generations forward: 27 descendants8 generations forward: 22 descendants9 generations forward: 21 descendants10 generations forward: 9 descendants11 generations forward: 2 descendants K990144 · 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 · recalled0+5+10
  1. Root · 3 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 2 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
  3. 1 generation backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
  4. This deviceK013416 Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc. · 2002
  5. Descendant · cites it directly · 251 of its ownK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
  6. Descendant · cites it directly · 231 of its ownK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
  7. Descendant · cites it directly · 230 of its ownK050369 Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc. · 2005 · Recalled
  8. Descendant · cites it directly · 229 of its ownK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
  9. Descendant · cites it directly · 229 of its ownK043288 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005

Showing 5 of 254 descendants. See all descendants

Descendants cleared per year

2004: 22005: 52006: 32008: 62009: 32011: 52012: 42013: 62014: 112015: 52016: 112017: 152018: 182019: 112020: 192021: 172022: 182023: 192024: 222025: 312026: 23
2004high 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 254 · See all
  • K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…Intuitive Surgical, Inc. · 2004 · cites it directly251descendants
  • K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…Intuitive Surgical, Inc. · 2005 · cites it directly231descendants
  • K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc. · 2005 · cites it directly230descendants
  • K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · cites it directly229descendants
  • K043288Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · cites it directly229descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K930667Reusable Laparoscopic InstrumentsSnowden-Pencer199415
−2K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer1996—
−1K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic…Intuitive Surgical, Inc.20003
0 (this device)K013416Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc.2002—
+1K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models…Intuitive Surgical, Inc.2004—
+1K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover…Intuitive Surgical, Inc.20052
+1K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc.200551
+1K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005—
+1K043288Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199310
199420
199510
199710
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200550
200630
200860
200930
201150
201240
201360
2014110
201550
2016110
2017150
2018180
2019110
2020190
2021170
2022180
2023191
2024220
2025310
2026230
FIG. 1 — Lineage of K013416, 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 GEI device

  1. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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? (4)

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
*K965001Intuitive Surgical Monarch Laparoscopic Manipulator
Summary page 1
…Device and Accessories Common Name: Endoscopic Forceps/Graspers/Needle Drivers/Scissors/Scalpels da Vinci™ Endoscopic Instrument Control System (legally marketed under K965001/K990144/K002489/K011002) The subject device(s) consist of a family of endoscopic instruments with either grasping or cutting end…
Intuitive Surgical, Inc.1997—
*K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…
Summary page 1
…nd Accessories Common Name: Endoscopic Forceps/Graspers/Needle Drivers/Scissors/Scalpels da Vinci™ Endoscopic Instrument Control System (legally marketed under K965001/K990144/K002489/K011002) The subject device(s) consist of a family of endoscopic instruments with either grasping or cutting end effecto…
Intuitive Surgical, Inc.20003
*K002489Intuitive Surgical DA Vinci Endoscopic Control System
Summary page 1
…sories Common Name: Endoscopic Forceps/Graspers/Needle Drivers/Scissors/Scalpels da Vinci™ Endoscopic Instrument Control System (legally marketed under K965001/K990144/K002489/K011002) The subject device(s) consist of a family of endoscopic instruments with either grasping or cutting end effectors to be…
Intuitive Surgical, Inc.2001—
*K011002Intuitive Surgical DA Vinci Surgical System, Model Isi 1000
Summary page 1
…Common Name: Endoscopic Forceps/Graspers/Needle Drivers/Scissors/Scalpels da Vinci™ Endoscopic Instrument Control System (legally marketed under K965001/K990144/K002489/K011002) The subject device(s) consist of a family of endoscopic instruments with either grasping or cutting end effectors to be used wi…
Intuitive Surgical, Inc.2001—

Also cleared against K965001: 3 other devices →

What descends from it? (254)

See all 254

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

NumberDeviceApplicantDecidedDescendants
K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…Intuitive Surgical, Inc.2004251
K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…Intuitive Surgical, Inc.2005231
K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc.2005230
K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005229
K043288Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005229
K040948Intuitive Surgical Endopass Endoscopic Delivery Instrument, Model P/N 400170Intuitive Surgical, Inc.2004229
K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005228
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

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 8 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
  • 2 of the 11 ancestors have a recall of any class.
  • Of its descendants, K043153 (Intuitive Surgical, Inc., 2004) has gone furthest, with 251 descendants of its own.
  • 3 other devices also cite its predicate K965001.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

Intuitive Surgical® Endoscopic Instruments including scissors, scalpels, forceps/pick-ups, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing.

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 K965001

3 other devices cite the same predicate.

  • K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2004
  • K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model DA Vinci Isi 1000/1200Intuitive Surgical, Inc. · 2002
  • K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 200218 recalls

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 GEI

The GEI category page

  • K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch…Stryker Instruments · 2026
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  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K013416 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013416: Intuitive Surgical Endowrist Endoscopic Instrument Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013416

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026