510(k) Report

510(k) · Cleared

Cleared

Auto Suture Endoscopic (& Open) TA Surgical Stapler, Auto Suture Endoscopic (& Open) Gia Surgical Stapling Instrument

K032696510(k) TraditionalCleared Dec 1, 200390-day reviewClass II21 CFR 878.4750

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 · GDW Staple, Implantable

Cleared on Dec 1, 2003 after a 90-day review. The FDA summary names its predicate without a number. 1 of the 85 devices in its family, counting itself, has a Class I recall. 84 later devices descend from it.

Decided
Dec 1, 2003
Review
90 days
Class
Class II
Product code
GDW
Recalls
None
Predicates
0

84 later devices descend from it, 4 citing it directly. 1 of the 85 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2010: 3 descendants cleared2011: 3 descendants cleared, 1 with a Class I recall12004: 1 descendant cleared2007: 4 descendants cleared2005: 1 descendant cleared2015: 4 descendants cleared2017: 10 descendants cleared2012: 5 descendants cleared2014: 7 descendants cleared2013: 5 descendants cleared2016: 7 descendants cleared2019: 3 descendants cleared2020: 4 descendants cleared2026: 3 descendants cleared2018: 5 descendants cleared2023: 5 descendants cleared2022: 5 descendants cleared2006: 1 descendant cleared2008: 2 descendants cleared2009: 1 descendant cleared2021: 5 descendants cleared200020052010201520202025
  1. This deviceK032696 Auto Suture Endoscopic (& Open) TA Surgical Stapler, Auto Suture…United States Surgical, A Division of Tyco Healthc · 2003
  2. Descendant · cites it directly · 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
  3. Descendant · cites it directly · 25 of its ownK040720 Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30…Power Medical Interventions, Inc. · 2004 · Recalled
  4. Descendant · 2 generations on · 21 of its ownK071708 I45, I45S, I60, and I60SPower Medical Interventions, Inc. · 2007 · Recalled
  5. Descendant · cites it directly · 18 of its ownK093679 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2010
  6. Descendant · 2 generations on · 15 of its ownK122276 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2012

Showing 5 of 84 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12006: 12007: 42008: 22009: 12010: 32011: 32012: 52013: 52014: 72015: 42016: 72017: 102018: 52019: 32020: 42021: 52022: 52023: 52026: 3
2004high 10 (2017) · low 0 (2024)2026

Class I recalls in this family

  • K111064 Tigerpaw System II2 generations on · 2011

Most influential descendants

Showing 5 of 84 · See all
  • 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 · cites it directly44descendants
  • K040720Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MMPower Medical Interventions, Inc. · 2004 · cites it directly25descendants
  • K071708I45, I45S, I60, and I60SPower Medical Interventions, Inc. · 2007 · 2 generations on21descendants
  • K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc. · 2010 · cites it directly18descendants
  • K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2012 · 2 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K032696Auto Suture Endoscopic (& Open) TA Surgical Stapler, Auto Suture Endoscopic (&…United States Surgical, A Division of Tyco Healthc2003—
+1K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA…Covidien, Formerly US Surgical A Divison of Tyco H201173
+1K040720Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55…Power Medical Interventions, Inc.20041
+2K071708I45, I45S, I60, and I60SPower Medical Interventions, Inc.20071
+1K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc.2010—
+2K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200610
200740
200820
200910
201030
201131
201250
201350
201470
201540
201670
2017100
201850
201930
202040
202150
202250
202350
202630
FIG. 1 — Lineage of K032696, 2003–2026Source: 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 GDW device

  1. #1 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.0 · 14 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? (1)

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
*—Auto Suture* TA* & GIA* Staplers
Named without a submission number
—

What descends from it? (84)

See all 84

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

NumberDeviceApplicantDecidedDescendants
K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Covidien, Formerly US Surgical A Divison of Tyco H201144
K040720Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MMPower Medical Interventions, Inc.200425
K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc.201018
K101961Tigerpaw SystemLaax, Inc.20102

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.

  • K111064Tigerpaw System IILaax, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

  • Of its descendants, K111825 (Covidien, Formerly US Surgical A Divison of Tyco H, 2011) has gone furthest, with 44 descendants of its own.

How does its category compare?

All GDW devices

GDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDW

3in 2025

2007: 82008: 72009: 132010: 102011: 112012: 92013: 132014: 152015: 82016: 112017: 132018: 72019: 122020: 102021: 92022: 72023: 42024: 22025: 32026 (partial year): 3
2007high 15 (2014) · low 2 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GDW

111in 2025

2007: 56 days median2008: 57 days median2009: 27 days median2010: 39 days median2011: 49 days median2012: 45 days median2013: 49 days median2014: 63 days median2015: 111 days median2016: 96 days median2017: 103 days median2018: 90 days median2019: 205 days median2020: 88 days median2021: 233 days median2022: 89 days median2023: 267 days median2025: 111 days median2026 (partial year): 141 days median
2007high 267 (2023) · low 27 (2009)2026

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

Recalls per year · GDW

3in 2025

2007: 92009: 222010: 22011: 92012: 11, 1 Class I2013: 12015: 62016: 22017: 32018: 32019: 4, 4 Class I2020: 112023: 12025: 3
2007high 22 (2009) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · GDW

11,905in 2025

2007: 2,4012008: 2,3802009: 4,0142010: 3,7682011: 3,8262012: 3,7172013: 3,7772014: 4,7842015: 4,8992016: 5,1062017: 11,6432018: 14,9142019: 16,6002020: 12,3322021: 13,0152022: 13,6052023: 14,6232024: 13,2802025: 11,905
2007high 16,600 (2019) · low 2,380 (2008)2025

MAUDE reports naming product code GDW, 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
200785692,401
200875702,380
20091327224,014
2010103923,768
2011114993,826
201294511 (1)3,717
2013134913,777
2014156304,784
2015811164,899
2016119625,106
201713103311,643
2018790314,914
2019122054 (4)16,600
202010881112,332
20219233013,015
2022789013,605
20234267114,623
20242—013,280
20253111311,905
202631410—

What is it indicated for?

The Auto Suture* TA* & knifeless GIA* staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses, including occlusion of the left atrial appendage in open procedures.

Indications for use as stated in the FDA summary.

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 GDW

The GDW category page

  • K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic…Ezisurg Medical Co., Ltd. · 2026
  • K260196ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler…Ethicon Endo-Surgery, LLC · 2026
  • K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads…Covidien (Part of Medtronic) · 2026
  • K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000…Ethicon Endo-Surgery, LLC · 2025
  • K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm…Ethicon Endo-Surgery, LLC · 2025

https://510kreport.com/device/K032696 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032696: Auto Suture Endoscopic (& Open) TA Surgical Stapler, Auto Suture Endoscopic (& Open) Gia Surgical Stapling Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032696

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026