510(k) Report

510(k) · Cleared

Cleared

Auto Suture Disposable Gia Surg. Stapler

K801590510(k) TraditionalCleared Aug 4, 198024-day reviewClass I21 CFR 878.4800

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 · FHM Apparatus, Suturing, Stomach And Intestinal

Cleared on Aug 4, 1980 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it.

Decided
Aug 4, 1980
Review
24 days
Class
Class I
Product code
FHM
Recalls
None
Predicates
0

24 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2011: 1 descendant cleared2010: 2 descendants cleared2012: 1 descendant cleared2021: 2 descendants cleared2014: 3 descendants cleared2019: 1 descendant cleared2013: 2 descendants cleared2022: 1 descendant cleared2016: 2 descendants cleared2018: 2 descendants cleared2017: 1 descendant cleared2023: 2 descendants cleared2020: 1 descendant cleared2025: 1 descendant cleared2024: 1 descendant cleared19801990200020102020
  1. This deviceK801590 Auto Suture Disposable Gia Surg. StaplerUnited States Surgical, A Division of Tyco Healthc · 1980
  2. Descendant · cites it directly · 21 of its ownK090821 Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21…Frankenman International Limited · 2009
  3. Descendant · 2 generations on · 17 of its ownK120179 Reach Surgical StaplersReach Surgical, Inc. · 2012
  4. Descendant · 3 generations on · 14 of its ownK131511 Disposable Circular Stapler, Disposable Curved Cutter Stapler…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013
  5. Descendant · 3 generations on · 7 of its ownK141367 LS Series Linear Stapler and Reloads, CLC Series Curved Linear…Touchstone International Medical Science Co., Ltd. · 2014
  6. Descendant · 4 generations on · 5 of its ownK173443 AEON Endoscopic StaplerLexington Medical, Inc. · 2018

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2009: 12010: 22011: 12012: 12013: 22014: 32016: 22017: 12018: 22019: 12020: 12021: 22022: 12023: 22024: 12025: 1
2009high 3 (2014) · low 0 (2015)2026

Most influential descendants

Showing 5 of 24 · See all
  • K090821Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32…Frankenman International Limited · 2009 · cites it directly21descendants
  • K120179Reach Surgical StaplersReach Surgical, Inc. · 2012 · 2 generations on17descendants
  • K131511Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013 · 3 generations on14descendants
  • K141367LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and Reloads, LC…Touchstone International Medical Science Co., Ltd. · 2014 · 3 generations on7descendants
  • K173443AEON Endoscopic StaplerLexington Medical, Inc. · 2018 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K801590Auto Suture Disposable Gia Surg. StaplerUnited States Surgical, A Division of Tyco Healthc1980—
+1K090821Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS…Frankenman International Limited2009—
+2K120179Reach Surgical StaplersReach Surgical, Inc.2012—
+3K131511Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable…Changzhou Sinolinks Medical Innovation Co., Ltd.2013—
+3K141367LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and…Touchstone International Medical Science Co., Ltd.2014—
+4K173443AEON Endoscopic StaplerLexington Medical, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201020
201110
201210
201320
201430
201620
201710
201820
201910
202010
202120
202210
202320
202410
202510
FIG. 1 — Lineage of K801590, 1980–2025Source: 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 FHM? 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
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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? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K090821Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32…Frankenman International Limited200921
K103470Panther Group of Surgical Includes: Oanther Circular Stapler; Panther Hemorrhoidal…B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.20111

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, K090821 (Frankenman International Limited, 2009) has gone furthest, with 21 descendants of its own.

How does its category compare?

All FHM devices

FHM Apparatus, Suturing, Stomach And Intestinal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FHM

FDA has decided no FHM device since 2007.

Median 510(k) review, days · FHM

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

Recalls per year · FHM

No recall names FHM since 2007.

Adverse event reports per year · FHM

1in 2024

2007: 12008: 32009: 52010: 12011: 22016: 22017: 62018: 82019: 32020: 52024: 1
2007high 8 (2018) · low 0 (2012)2025

MAUDE reports naming product code FHM, 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—01
20080—03
20090—05
20100—01
20110—02
20120—00
20130—00
20140—00
20150—00
20160—02
20170—06
20180—08
20190—03
20200—05
20210—00
20220—00
20230—00
20240—01
20250—00
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 FHM

The FHM category page

  • K801589Auto Suture Disp. 30, Etc. & Surg. StapUnited States Surgical, A Division of Tyco Healthc · 1980

https://510kreport.com/device/K801590 · printed Nov 4, 2026

Cite this page

510(k) Report. “K801590: Auto Suture Disposable Gia Surg. Stapler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K801590

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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