510(k) Report

510(k) · Cleared

Cleared

Auto Suture Modified Endo Stream Suc./Irri. Device

K905426510(k) TraditionalCleared Feb 11, 199169-day reviewClass II21 CFR 884.1720

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 · HET Laparoscope, Gynecologic (And Accessories)

Cleared on Feb 11, 1991 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 53 later devices descend from it.

Decided
Feb 11, 1991
Review
69 days
Class
Class II
Product code
HET
Recalls
None
Predicates
0

53 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2021: 6 descendants cleared2013: 2 descendants cleared2020: 4 descendants cleared2012: 1 descendant cleared2014: 4 descendants cleared2017: 2 descendants cleared2016: 1 descendant cleared2023: 7 descendants cleared2018: 3 descendants cleared2015: 1 descendant cleared2024: 7 descendants cleared2019: 2 descendants cleared2026: 3 descendants cleared2025: 8 descendants cleared2022: 1 descendant cleared1990200020102020
  1. This deviceK905426 Auto Suture Modified Endo Stream Suc./Irri. DeviceUnited States Surgical, A Division of Tyco Healthc · 1991
  2. Descendant · cites it directly · 52 of its ownK091869 Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsCovidien Lp, Formerly Registered AS United States · 2009
  3. Descendant · 2 generations on · 39 of its ownK122532 DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2013 · Recalled
  4. Descendant · 3 generations on · 22 of its ownK131962 DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2014
  5. Descendant · 4 generations on · 21 of its ownK173906 da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2018 · Recalled
  6. Descendant · 5 generations on · 20 of its ownK182371 da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2019 · Recalled

Showing 5 of 53 descendants. See all descendants

Descendants cleared per year

2009: 12012: 12013: 22014: 42015: 12016: 12017: 22018: 32019: 22020: 42021: 62022: 12023: 72024: 72025: 82026: 3
2009high 8 (2025) · low 0 (2010)2026

Most influential descendants

Showing 5 of 53 · See all
  • K091869Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsCovidien Lp, Formerly Registered AS United States · 2009 · cites it directly52descendants
  • K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2013 · 2 generations on39descendants
  • K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2014 · 3 generations on22descendants
  • K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2018 · 4 generations on21descendants
  • K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2019 · 5 generations on20descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K905426Auto Suture Modified Endo Stream Suc./Irri. DeviceUnited States Surgical, A Division of Tyco Healthc1991—
+1K091869Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsCovidien Lp, Formerly Registered AS United States2009—
+2K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc.20136
+3K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2014—
+4K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.20189
+5K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.20194

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201210
201320
201440
201510
201610
201720
201830
201920
202040
202160
202210
202370
202470
202580
202630
FIG. 1 — Lineage of K905426, 1991–2026Source: 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.

Planning a device in HET? 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 HET device

  1. #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 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?

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

What descends from it? (53)

See all 53

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K091869Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsCovidien Lp, Formerly Registered AS United States200952

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?

  • Of its descendants, K091869 (Covidien Lp, Formerly Registered AS United States, 2009) has gone furthest, with 52 descendants of its own.

How does its category compare?

All HET devices

HET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HET

2in 2025

2008: 32009: 12010: 12011: 22012: 22013: 22015: 22017: 22018: 12019: 22020: 22021: 42022: 12025: 2
2007high 4 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HET

269in 2021

2008: 176 days median2021: 269 days median
2007high 269 (2021) · low 176 (2008)2026

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

Recalls per year · HET

4in 2023

2008: 42009: 12015: 12022: 12023: 4
2007high 4 (2008) · low 0 (2007)2026

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

Adverse event reports per year · HET

4,513in 2025

2007: 1812008: 3592009: 4032010: 2142011: 4172012: 1,1182013: 1,0352014: 1752015: 1242016: 2052017: 892018: 532019: 442020: 492021: 1322022: 2162023: 8242024: 3,4962025: 4,513
2007high 4,513 (2025) · low 44 (2019)2025

MAUDE reports naming product code HET, 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—0181
200831764359
20091—1403
20101—0214
20112—0417
20122—01,118
20132—01,035
20140—0175
20152—1124
20160—0205
20172—089
20181—053
20192—044
20202—049
202142690132
20221—1216
20230—4824
20240—03,496
20252—04,513
20260—0—

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 HET

The HET category page

  • K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) Limited · 2025
  • K243821i-CutA.M.I. Agency For Medical Innovations GmbH · 2025
  • K221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) Limited · 2022
  • K210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2021
  • K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp. · 20211 recall

https://510kreport.com/device/K905426 · printed Nov 6, 2026

Cite this page

510(k) Report. “K905426: Auto Suture Modified Endo Stream Suc./Irri. Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905426

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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