510(k) Report

510(k) · Cleared

Cleared

Auto Suture Endo Clip Iii 5 MM Clip Applier

K061288510(k) SpecialCleared Nov 2, 2006177-day reviewClass II21 CFR 878.4300

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 · FZP Clip, Implantable

Cleared on Nov 2, 2006 as substantially equivalent to K883018 (United States Surgical, A Division of Tyco Healthc, 1988) after a 177-day review. Its family tree reaches back 1 generation to 1988. 8 later devices descend from it.

Decided
Nov 2, 2006
Review
177 days
Class
Class II
Product code
FZP
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K883018 (1988). 8 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2015: 1 descendant cleared2007: 1 descendant cleared2012: 1 descendant cleared2024: 1 descendant cleared2022: 1 descendant cleared2025: 2 descendants clearedK883018 · Auto Suture Disp. Endoscopic Surg. Clip Applier · United States Surgical, A Division of Tyco Healthc · 19881990200020102020
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 2 descendants K883018 · Auto Suture Disp. Endoscopic Surg. Clip Applier · United States Surgical, A Division of Tyco Healthc · 19880
  1. Root · 1 generation backK883018 Auto Suture Disp. Endoscopic Surg. Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1988
  2. This deviceK061288 Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2006
  3. Descendant · cites it directly · 5 of its ownK071406 Autosuture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2007
  4. Descendant · 2 generations on · 3 of its ownK121194 Endo Clip Iii 5MM Clip ApplierCovidien · 2012
  5. Descendant · 3 generations on · 2 of its ownK202994 InnoClip Disposable Clip Applier, InnoClip Clip ApplierTaiwan Surgical Corporation · 2022
  6. Descendant · cites it directly · 1 of its ownK143644 Premium Surgiclip¿; Endo Clip¿; AcuClip¿Covidien · 2015
  7. Descendant · 4 generations on · 0 of its ownK253781 InnoClip Clip ApplierTaiwan Surgical Corporation · 2025

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2007: 12010: 12012: 12015: 12022: 12024: 12025: 2
2007high 2 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 8 · See all
  • K071406Autosuture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2007 · cites it directly5descendants
  • K121194Endo Clip Iii 5MM Clip ApplierCovidien · 2012 · 2 generations on3descendants
  • K202994InnoClip Disposable Clip Applier, InnoClip Clip ApplierTaiwan Surgical Corporation · 2022 · 3 generations on2descendants
  • K143644Premium Surgiclip¿; Endo Clip¿; AcuClip¿Covidien · 2015 · cites it directly1descendant
  • K253781InnoClip Clip ApplierTaiwan Surgical Corporation · 2025 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K883018Auto Suture Disp. Endoscopic Surg. Clip ApplierUnited States Surgical, A Division of Tyco Healthc1988—
0 (this device)K061288Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc2006—
+1K071406Autosuture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc2007—
+2K121194Endo Clip Iii 5MM Clip ApplierCovidien2012—
+3K202994InnoClip Disposable Clip Applier, InnoClip Clip ApplierTaiwan Surgical Corporation2022—
+1K143644Premium Surgiclip¿; Endo Clip¿; AcuClip¿Covidien2015—
+4K253781InnoClip Clip ApplierTaiwan Surgical Corporation2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201010
201210
201510
202210
202410
202520
FIG. 1 — Lineage of K061288, 1988–2025Source: 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.

Planning a device in FZP? 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 FZP device

  1. #1 K260677 Vessel Closure Device (VCD177213P)score 12.6 · 3 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? (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
*K883018Auto Suture Disp. Endoscopic Surg. Clip Applier
Summary page 1
…Implantable Clip CLASSIFICATION NAME: Implantable Clip PREDICATE DEVICE(S): Auto SutureTM ENDO CLIP TM Disposable Clip Applier (K883018) DEVICE DESCRIPTION: The Auto SutureTM ENDO CLIP T M III 5mm Clip Applier contai…
United States Surgical, A Division of Tyco Healthc1988—

Also cleared against K883018: 3 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K071406Autosuture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc20075
K143644Premium Surgiclip¿; Endo Clip¿; AcuClip¿Covidien20151
K100242Auto Suture Endo Clip III5MM Clip AdapterSurgical Devices, A Division of Tyco Healthcare20100

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?

  • Its one ancestor has no recall.
  • Of its descendants, K071406 (United States Surgical, A Division of Tyco Healthc, 2007) has gone furthest, with 5 descendants of its own.
  • 3 other devices also cite its predicate K883018.

How does its category compare?

All FZP devices

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

FDA decisions per year · FZP

5in 2025

2007: 62008: 42009: 32010: 62011: 32012: 22013: 32014: 32015: 82016: 52017: 42018: 42019: 12020: 22022: 32023: 32024: 22025: 52026 (partial year): 2
2007high 8 (2015) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FZP

90in 2025

2007: 31 days median2008: 23 days median2009: 22 days median2010: 47 days median2011: 124 days median2013: 47 days median2014: 29 days median2015: 182 days median2016: 72 days median2017: 29 days median2018: 143 days median2022: 227 days median2023: 65 days median2025: 90 days median
2007high 227 (2022) · low 22 (2009)2026

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

Recalls per year · FZP

1in 2020

2007: 12008: 62010: 12012: 12014: 12016: 22017: 12019: 32020: 1
2007high 6 (2008) · low 0 (2009)2026

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

Adverse event reports per year · FZP

1,902in 2025

2007: 1,8772008: 9812009: 2,1602010: 2,3672011: 1,6782012: 1,6772013: 2,3812014: 2,3202015: 2,8712016: 1,8402017: 2,5942018: 2,7182019: 2,9032020: 1,7602021: 1,7592022: 1,5752023: 1,9182024: 2,0672025: 1,902
2007high 2,903 (2019) · low 981 (2008)2025

MAUDE reports naming product code FZP, 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
200763111,877
20084236981
200932202,160
201064712,367
2011312401,678
20122—11,677
201334702,381
201432912,320
2015818202,871
201657221,840
201742912,594
2018414302,718
20191—32,903
20202—11,760
20210—01,759
2022322701,575
202336501,918
20242—02,067
202559001,902
20262—0—

What is it indicated for?

The Auto Suture TM ENDO CLIP TM III 5mm Clip Applier has applications in many types of endoscopic procedures to achieve hemostasis following transection of vessels and other tubular structures, and for radiographic markings.

Indications for use as stated in the FDA summary.

Also cleared against K883018

3 other devices cite the same predicate.

  • K143644Premium Surgiclip¿; Endo Clip¿; AcuClip¿Covidien · 2015
  • K100242Auto Suture Endo Clip III5MM Clip AdapterSurgical Devices, A Division of Tyco Healthcare · 2010
  • K072814Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic ProceduresCovidien · 2008

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
  • 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
  • K061095Auto Sutur Endo Gia StaplersUnited States Surgical, A Division of Tyco Healthc · 2006

Recent decisions in FZP

The FZP category page

  • K260677Vessel Closure Device (VCD177213P)Vcd Medical S.R.L. · 2026
  • K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical Corporation · 2026
  • K253903InnoClip Disposable Clip ApplierTaiwan Surgical Corporation · 2025
  • K253781InnoClip Clip ApplierTaiwan Surgical Corporation · 2025
  • K250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd. · 2025

https://510kreport.com/device/K061288 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061288: Auto Suture Endo Clip Iii 5 MM Clip Applier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061288

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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