510(k) Report

510(k) · Cleared

Cleared

Modification Auto Suture (R) Endoscopic Clamp

K904578510(k) TraditionalCleared Oct 30, 199028-day reviewClass I21 CFR 878.4820

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 · GET Motor, Surgical Instrument, Pneumatic Powered

Cleared on Oct 30, 1990 after a 28-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
Oct 30, 1990
Review
28 days
Class
Class I
Product code
GET
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 deviceK904578 Modification Auto Suture (R) Endoscopic ClampUnited States Surgical, A Division of Tyco Healthc · 1990
  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)K904578Modification Auto Suture (R) Endoscopic ClampUnited States Surgical, A Division of Tyco Healthc1990—
+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 K904578, 1990–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GET? 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? (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 GET devices

GET Motor, Surgical Instrument, Pneumatic Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GET

FDA has decided no GET device since 2007.

Median 510(k) review, days · GET

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

Recalls per year · GET

1in 2013

2008: 472013: 1
2007high 47 (2008) · low 0 (2007)2026

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

Adverse event reports per year · GET

8in 2025

2007: 332008: 82009: 112010: 352011: 2802012: 482013: 342014: 262015: 432016: 292017: 452018: 462019: 152020: 152021: 92022: 132023: 62024: 192025: 8
2007high 280 (2011) · low 6 (2023)2025

MAUDE reports naming product code GET, 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—033
20080—478
20090—011
20100—035
20110—0280
20120—048
20130—134
20140—026
20150—043
20160—029
20170—045
20180—046
20190—015
20200—015
20210—09
20220—013
20230—06
20240—019
20250—08
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 GET

The GET category page

  • K960473Aesculap Power System HandpieceAesculap, Inc. · 1996
  • K955174Sodem High Speed System for Neurosurgery & Median StyernotomySodem Diffusion SA · 1996
  • K942987Nucleotome L KitSurgical Dynamics, Inc. · 1995
  • K954076Midas Rex Drill Attachments & Twist DrillsMidas Rex Pneumatic Tools, Inc. · 1995
  • K953433Midas Rex Telescoping SystemMidas Rex Pneumatic Tools, Inc. · 19952 recalls

https://510kreport.com/device/K904578 · printed Nov 6, 2026

Cite this page

510(k) Report. “K904578: Modification Auto Suture (R) Endoscopic Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K904578

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
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026