510(k) Report

510(k) · Cleared

Cleared

Auto Suture (R) Endoscopic Fan Retractor

K914190510(k) TraditionalCleared May 6, 1992231-day reviewClass I21 CFR 878.4800

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

United States Surgical, A Division of Tyco Healthc · GAD Retractor

Cleared on May 6, 1992 after a 231-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 272 devices in its family, counting itself, has a Class I recall. 271 later devices descend from it.

Decided
May 6, 1992
Review
231 days
Class
Class I
Product code
GAD
Recalls
None
Predicates
0

271 later devices descend from it, 5 citing it directly. 1 of the 272 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2009: 4 descendants cleared2012: 5 descendants cleared2016: 14 descendants cleared2014: 12 descendants cleared1997: 1 descendant cleared2002: 3 descendants cleared2004: 4 descendants cleared2008: 6 descendants cleared2005: 5 descendants cleared2006: 3 descendants cleared2025: 32 descendants cleared2011: 6 descendants cleared2010: 1 descendant cleared2018: 18 descendants cleared2024: 22 descendants cleared2017: 15 descendants cleared2022: 18 descendants cleared2013: 6 descendants cleared2019: 12 descendants cleared2020: 19 descendants cleared2021: 17 descendants cleared2015: 6 descendants cleared2026: 23 descendants cleared2023: 19 descendants cleared, 1 with a Class I recall11990200020102020
  1. This deviceK914190 Auto Suture (R) Endoscopic Fan RetractorUnited States Surgical, A Division of Tyco Healthc · 1992
  2. Descendant · cites it directly · 263 of its ownK965001 Intuitive Surgical Monarch Laparoscopic ManipulatorIntuitive Surgical, Inc. · 1997
  3. Descendant · 2 generations on · 260 of its ownK022574 Intuitive Surgical Endoscopic Instrument Control System & Endoscopic…Intuitive Surgical, Inc. · 2002
  4. Descendant · 2 generations on · 260 of its ownK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
  5. Descendant · 2 generations on · 258 of its ownK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
  6. Descendant · 2 generations on · 254 of its ownK013416 Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc. · 2002

Showing 5 of 271 descendants. See all descendants

Descendants cleared per year

1997: 12002: 32004: 42005: 52006: 32008: 62009: 42010: 12011: 62012: 52013: 62014: 122015: 62016: 142017: 152018: 182019: 122020: 192021: 172022: 182023: 192024: 222025: 322026: 23
1997high 32 (2025) · low 0 (1998)2026

Class I recalls in this family

  • K223095 Senhance Surgical System5 generations on · 2023

Most influential descendants

Showing 5 of 271 · See all
  • K965001Intuitive Surgical Monarch Laparoscopic ManipulatorIntuitive Surgical, Inc. · 1997 · cites it directly263descendants
  • K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…Intuitive Surgical, Inc. · 2002 · 2 generations on260descendants
  • K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · 2 generations on260descendants
  • K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…Intuitive Surgical, Inc. · 2004 · 2 generations on258descendants
  • K013416Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc. · 2002 · 2 generations on254descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K914190Auto Suture (R) Endoscopic Fan RetractorUnited States Surgical, A Division of Tyco Healthc1992—
+1K965001Intuitive Surgical Monarch Laparoscopic ManipulatorIntuitive Surgical, Inc.1997—
+2K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic…Intuitive Surgical, Inc.2002—
+2K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc.200218
+2K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc.2004—
+2K013416Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200230
200440
200550
200630
200860
200940
201010
201160
201250
201360
2014120
201560
2016140
2017150
2018180
2019120
2020190
2021170
2022180
2023191
2024220
2025320
2026230
FIG. 1 — Lineage of K914190, 1992–2026Source: 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), 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.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (271)

See all 271

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

NumberDeviceApplicantDecidedDescendants
K965001Intuitive Surgical Monarch Laparoscopic ManipulatorIntuitive Surgical, Inc.1997263
K133345Reveel Endoscopic RetractorRetraction Limited20142
K082291A-Lap Set (a-Lap, Ezaxess, Trocar)Ezsurgical20091
K152538JRP Wound SpreaderJ.R. Parker, LLC20160
K112659Surgical RetractorsSurgical Innovations Plc20120

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 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K965001 (Intuitive Surgical, Inc., 1997) has gone furthest, with 263 descendants of its own.

How does its category compare?

All GAD devices

GAD Retractor: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAD

2in 2016

2007: 12013: 12016: 2
2007high 2 (2016) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAD

Too few GAD 510(k)s in any year since 2007 to give a median.

Recalls per year · GAD

1in 2024

2008: 12009: 12013: 32014: 22015: 12022: 12024: 12026 (partial year): 1
2007high 3 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GAD

107in 2025

2007: 382008: 452009: 642010: 522011: 502012: 802013: 882014: 802015: 672016: 782017: 902018: 772019: 622020: 862021: 812022: 802023: 802024: 1112025: 107
2007high 111 (2024) · low 38 (2007)2025

MAUDE reports naming product code GAD, 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
20071—038
20080—145
20090—164
20100—052
20110—050
20120—080
20131—388
20140—280
20150—167
20162—078
20170—090
20180—077
20190—062
20200—086
20210—081
20220—180
20230—080
20240—1111
20250—0107
20260—1—

More from United States Surgical, A Division of…

218 FDA decisions under this applicant name. See the company

  • K071406Autosuture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2007
  • K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
  • K061288Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062850Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062326Autosuture Modified Versaport Trocar with Fixation SleeveUnited States Surgical, A Division of Tyco Healthc · 2006

Recent decisions in GAD

The GAD category page

  • K152538JRP Wound SpreaderJ.R. Parker, LLC · 2016
  • K151104Otelo LLSpineart · 2016
  • K132645Thoratrak Mics Retractor System, Rack, BladesMedtronic, Inc. · 2013
  • K071775DASHEzsurgical · 2007
  • K050256Apple Medical/OB Mobius Elastic RetractorApple Medical Corp. · 2005

https://510kreport.com/device/K914190 · printed Nov 6, 2026

Cite this page

510(k) Report. “K914190: Auto Suture (R) Endoscopic Fan Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914190

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026