510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Autosuture Endoscopic Suturing Device

K934738510(k) TraditionalCleared Mar 16, 1994166-day reviewClass II21 CFR 876.1500Recalls 2

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 · OCW Endoscopic Tissue Approximation Device

Cleared on Mar 16, 1994 after a 166-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 78 later devices descend from it. It has been recalled 2 times.

Decided
Mar 16, 1994
Review
166 days
Class
Class II
Product code
OCW
Recalls
2
Predicates
0

78 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2000: 2 descendants cleared2011: 3 descendants cleared2008: 3 descendants cleared2016: 7 descendants cleared2021: 4 descendants cleared2009: 3 descendants cleared2001: 2 descendants cleared2007: 3 descendants cleared2002: 1 descendant cleared2010: 4 descendants cleared2012: 6 descendants cleared2014: 7 descendants cleared2019: 1 descendant cleared2017: 8 descendants cleared2020: 4 descendants cleared2026: 1 descendant cleared2013: 4 descendants cleared2018: 2 descendants cleared2023: 3 descendants cleared2022: 4 descendants cleared2015: 5 descendants cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK934738 Autosuture Endoscopic Suturing DeviceUnited States Surgical, A Division of Tyco Healthc · 1994
  2. Descendant · cites it directly · 50 of its ownK082659 Modified Endo StichCovidien Lp, Formerly Registered AS United States · 2008
  3. Descendant · 2 generations on · 47 of its ownK090419 Sils Stitch Endoscopic Suturing DeviceCovidien Lp, Formerly Registered AS United States · 2009
  4. Descendant · 3 generations on · 45 of its ownK103263 Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010
  5. Descendant · 4 generations on · 44 of its ownK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
  6. Descendant · cites it directly · 23 of its ownK994290 Bard Endoscopic Suturing SystemC.R. Bard, Inc. · 2000

Showing 5 of 78 descendants. See all descendants

Descendants cleared per year

2000: 22001: 22002: 12007: 32008: 32009: 32010: 42011: 32012: 62013: 42014: 72015: 52016: 72017: 82018: 22019: 12020: 42021: 42022: 42023: 32024: 12026: 1
2000high 8 (2017) · low 0 (2003)2026

Most influential descendants

Showing 5 of 78 · See all
  • K082659Modified Endo StichCovidien Lp, Formerly Registered AS United States · 2008 · cites it directly50descendants
  • K090419Sils Stitch Endoscopic Suturing DeviceCovidien Lp, Formerly Registered AS United States · 2009 · 2 generations on47descendants
  • K103263Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010 · 3 generations on45descendants
  • K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · 4 generations on44descendants
  • K994290Bard Endoscopic Suturing SystemC.R. Bard, Inc. · 2000 · cites it directly23descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K934738Autosuture Endoscopic Suturing DeviceUnited States Surgical, A Division of Tyco Healthc1994—
+1K082659Modified Endo StichCovidien Lp, Formerly Registered AS United States2008—
+2K090419Sils Stitch Endoscopic Suturing DeviceCovidien Lp, Formerly Registered AS United States2009—
+3K103263Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H2010—
+4K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA…Covidien, Formerly US Surgical A Divison of Tyco H201173
+1K994290Bard Endoscopic Suturing SystemC.R. Bard, Inc.2000—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200020
200120
200210
200730
200830
200930
201040
201130
201260
201340
201470
201550
201670
201780
201820
201910
202040
202140
202240
202330
202410
202610
FIG. 1 — Lineage of K934738, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OCW? 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 OCW device

  1. #1 K252400 Endomina EZFuse systemscore 12.0 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (78)

See all 78

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

NumberDeviceApplicantDecidedDescendants
K082659Modified Endo StichCovidien Lp, Formerly Registered AS United States200850
K994290Bard Endoscopic Suturing SystemC.R. Bard, Inc.200023
K994087SuperstitchSutura, Inc.20002
K111442V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo Stitch (TM)…Covidien, Formerly US Surgical A Divison of Tyco H20110

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 15, 2026Class IIZ-2281-2026Process controlThe presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
May 3, 2017Class IIZ-2543-2017Process controlPotential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K082659 (Covidien Lp, Formerly Registered AS United States, 2008) has gone furthest, with 50 descendants of its own.

How does its category compare?

All OCW devices

OCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OCW

1in 2025

2007: 52008: 42009: 32010: 42011: 12012: 12013: 22016: 22017: 22018: 22019: 12020: 12021: 32023: 32025: 12026 (partial year): 2
2007high 5 (2007) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCW

133in 2023

2007: 58 days median2008: 70 days median2009: 30 days median2010: 91 days median2021: 221 days median2023: 133 days median
2007high 221 (2021) · low 30 (2009)2026

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

Recalls per year · OCW

3so far in 2026, the most since 2007

2023: 12026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

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

Adverse event reports per year · OCW

326in 2025

2007: 92008: 472009: 302010: 102011: 162012: 282013: 22014: 282015: 592016: 742017: 4202018: 4132019: 2912020: 1832021: 1982022: 2352023: 2272024: 2112025: 326
2007high 420 (2017) · low 2 (2013)2025

MAUDE reports naming product code OCW, 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
200755809
2008470047
2009330030
2010491010
20111—016
20121—028
20132—02
20140—028
20150—059
20162—074
20172—0420
20182—0413
20191—0291
20201—0183
202132210198
20220—0235
202331331227
20240—0211
20251—0326
20262—3—

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 OCW

The OCW category page

  • K262044Mediclose Cartridge SystemHealth Value Creation B.V. (trading as Corporis Medical) · 2026
  • K252400Endomina EZFuse systemEndo Tools Therapeutics S.A. · 2026
  • K243750SimpleStitch Suturing SystemEnvision Endoscopy · 2025
  • K231240MaxTack™ Motorized Fixation DeviceCovidien · 2023
  • K213271MedicloseTM SystemHealth Value Creation B.V., Trading AS Corporis Medical · 2023

https://510kreport.com/device/K934738 · printed Nov 5, 2026

Cite this page

510(k) Report. “K934738: Autosuture Endoscopic Suturing Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K934738

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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