510(k) Report

510(k) · Cleared

Cleared

Auto Suture (R) Powered Endoscopic Gia (TM) Stapler

K913802510(k) TraditionalCleared Oct 17, 199152-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 Oct 17, 1991 after a 52-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 109 devices in its family, counting itself, has a Class I recall. 108 later devices descend from it.

Decided
Oct 17, 1991
Review
52 days
Class
Class II
Product code
GDW
Recalls
None
Predicates
0

108 later devices descend from it, 3 citing it directly. 1 of the 109 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2001: 1 descendant cleared2002: 6 descendants cleared2004: 5 descendants cleared2005: 5 descendants cleared2010: 4 descendants cleared2012: 5 descendants cleared2016: 8 descendants cleared2014: 8 descendants cleared, 1 with a Class I recall12007: 9 descendants cleared2009: 4 descendants cleared2015: 4 descendants cleared2017: 8 descendants cleared2011: 4 descendants cleared2025: 3 descendants cleared2023: 4 descendants cleared2003: 1 descendant cleared2019: 5 descendants cleared2006: 5 descendants cleared2026: 5 descendants cleared2021: 3 descendants cleared2008: 2 descendants cleared2022: 2 descendants cleared2013: 1 descendant cleared2018: 4 descendants cleared2020: 2 descendants cleared1990200020102020
  1. This deviceK913802 Auto Suture (R) Powered Endoscopic Gia (TM) StaplerUnited States Surgical, A Division of Tyco Healthc · 1991
  2. Descendant · cites it directly · 87 of its ownK020779 Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. · 2002 · Recalled
  3. Descendant · cites it directly · 66 of its ownK012809 Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45Power Medical Interventions, Inc. · 2001
  4. Descendant · 2 generations on · 47 of its ownK020719 Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM…Power Medical Interventions, Inc. · 2002 · Recalled
  5. Descendant · 2 generations on · 46 of its ownK030653 Surgassist Straight Linear Stapler and Straight Linear 4 Row NO…Power Medical Interventions, Inc. · 2003
  6. Descendant · 3 generations on · 45 of its ownK040398 Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004

Showing 5 of 108 descendants. See all descendants

Descendants cleared per year

2001: 12002: 62003: 12004: 52005: 52006: 52007: 92008: 22009: 42010: 42011: 42012: 52013: 12014: 82015: 42016: 82017: 82018: 42019: 52020: 22021: 32022: 22023: 42025: 32026: 5
2001high 9 (2007) · low 0 (2024)2026

Class I recalls in this family

  • K141952 Echelon Flex Powered Vascular Stapler with…2 generations on · 2014

Most influential descendants

Showing 5 of 108 · See all
  • K020779Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. · 2002 · cites it directly87descendants
  • K012809Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45Power Medical Interventions, Inc. · 2001 · cites it directly66descendants
  • K020719Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with Blue and…Power Medical Interventions, Inc. · 2002 · 2 generations on47descendants
  • K030653Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital Loading…Power Medical Interventions, Inc. · 2003 · 2 generations on46descendants
  • K040398Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004 · 3 generations on45descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K913802Auto Suture (R) Powered Endoscopic Gia (TM) StaplerUnited States Surgical, A Division of Tyco Healthc1991—
+1K020779Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc.200217
+1K012809Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45Power Medical Interventions, Inc.2001—
+2K020719Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with…Power Medical Interventions, Inc.20021
+2K030653Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital…Power Medical Interventions, Inc.2003—
+3K040398Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200260
200310
200450
200550
200650
200790
200820
200940
201040
201140
201250
201310
201481
201540
201680
201780
201840
201950
202020
202130
202220
202340
202530
202650
FIG. 1 — Lineage of K913802, 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.

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 15.1 · 14 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? (108)

See all 108

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

NumberDeviceApplicantDecidedDescendants
K020779Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc.200287
K012809Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45Power Medical Interventions, Inc.200166
K043115Laparoscopic Compression Anastomosis Clip (Lapcac)Niti Medical Technologies, Ltd.20045

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.

  • K141952Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads…Ethicon Endo-Surgery, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K020779 (Ethicon Endo-Surgery, Inc., 2002) has gone furthest, with 87 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—

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/K913802 · printed Nov 4, 2026

Cite this page

510(k) Report. “K913802: Auto Suture (R) Powered Endoscopic Gia (TM) Stapler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K913802

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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