510(k) Report

510(k) · Cleared

Cleared

Premium Surgiclip¿; Endo Clip¿; AcuClip¿

K143644510(k) TraditionalCleared Sep 14, 2015266-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

Covidien · FZP Clip, Implantable

Cleared on Sep 14, 2015 as substantially equivalent to K853650 (United States Surgical, A Division of Tyco Healthc, 1985) and 4 other predicates after a 266-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.

Decided
Sep 14, 2015
Review
266 days
Class
Class II
Product code
FZP
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K883018 (1988). 5 ancestors in all, the oldest K853650 (1985). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2014: 1 other ancestor1992: 1 other ancestor1985: 1 other ancestor2024: 1 descendant clearedK883018 · Auto Suture Disp. Endoscopic Surg. Clip Applier · United States Surgical, A Division of Tyco Healthc · 1988K061288 · Auto Suture Endo Clip Iii 5 MM Clip Applier · United States Surgical, A Division of Tyco Healthc · 20061990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant K061288 · Auto Suture Endo Clip Iii 5 MM Clip Applier · United States Surgical, A Division of Tyco Healthc · 2006K883018 · Auto Suture Disp. Endoscopic Surg. Clip Applier · United States Surgical, A Division of Tyco Healthc · 19880
  1. Root · 2 generations backK883018 Auto Suture Disp. Endoscopic Surg. Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1988
  2. 1 generation backK061288 Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2006
  3. This deviceK143644 Premium Surgiclip¿; Endo Clip¿; AcuClip¿Covidien · 2015
  4. Descendant · cites it directly · 0 of its ownK221495 SOLID CLIP™ Single Use Clip ApplierMedscope Biotech Co., Ltd. · 2024

Most influential descendants

Showing 1 of 1 · See all
  • K221495SOLID CLIP™ Single Use Clip ApplierMedscope Biotech Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K883018Auto Suture Disp. Endoscopic Surg. Clip ApplierUnited States Surgical, A Division of Tyco Healthc1988—
−1K061288Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc2006—
0 (this device)K143644Premium Surgiclip¿; Endo Clip¿; AcuClip¿Covidien2015—
+1K221495SOLID CLIP™ Single Use Clip ApplierMedscope Biotech Co., Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199210
201410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
FIG. 1 — Lineage of K143644, 1988–2024Source: 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? (5)

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
*K853650Auto Suture Titanium Hemostatic Clip
Summary page 6
…Pursuant to 21 CFR § 878.4300 implantable clips are Class II devices PREDICATE DEVICE(S): Premium Surgiclip™ III (K853650), (K142869) Endo Clip™ (K061288), (K883018) AcuClip™…
United States Surgical, A Division of Tyco Healthc1985—
*K142869Premium Surgiclip III
Summary page 6
…21 CFR § 878.4300 implantable clips are Class II devices PREDICATE DEVICE(S): Premium Surgiclip™ III (K853650), (K142869) Endo Clip™ (K061288), (K883018) AcuClip™ (K920599)…
Covidien2014—
*K061288Auto Suture Endo Clip Iii 5 MM Clip Applier
Summary page 6
…are Class II devices PREDICATE DEVICE(S): Premium Surgiclip™ III (K853650), (K142869) Endo Clip™ (K061288), (K883018) AcuClip™ (K920599)…
United States Surgical, A Division of Tyco Healthc2006—
*K883018Auto Suture Disp. Endoscopic Surg. Clip Applier
Summary page 6
…are Class II devices PREDICATE DEVICE(S): Premium Surgiclip™ III (K853650), (K142869) Endo Clip™ (K061288), (K883018) AcuClip™ (K920599) K1…
United States Surgical, A Division of Tyco Healthc1988—
*K920599Hook Surgical Instrument
Summary page 6
…Premium Surgiclip™ III (K853650), (K142869) Endo Clip™ (K061288), (K883018) AcuClip™ (K920599) K143644, Page 2 of 5 INTENDED USE: Premium Surgiclip™…
Origin Medsystems, Inc.1992—

Also cleared against K853650: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K221495SOLID CLIP™ Single Use Clip ApplierMedscope Biotech Co., Ltd.20240

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?

  • The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 18.2 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K221495 (Medscope Biotech Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K853650.

How does its category compare?

All FZP devices

FZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

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 Premium Surgiclip™ clip applier has application in many types of surgical procedures to occlude vessels and other tubular structures and for vagotomy. sympathectomy and radiographic markings Endo Clip™ M, ML, L - The Endo Clip™ clip applier has application in endoscopic procedures to achieve occlusion of vessels and other tubular structures. and for radiographic markings. Endo Clip™ 5mm - The Endo Clip™ clip applier has applications in endoscopic…

Read the full statement (152 words)

The Premium Surgiclip™ clip applier has application in many types of surgical procedures to occlude vessels and other tubular structures and for vagotomy. sympathectomy and radiographic markings

Endo Clip™ M, ML, L - The Endo Clip™ clip applier has application in endoscopic procedures to achieve occlusion of vessels and other tubular structures. and for radiographic markings.

Endo Clip™ 5mm - The Endo Clip™ clip applier has applications in endoscopic procedures to achieve occlusion of vessels and other tubular structures and for radiographic markings.

Endo Clip™ II - The Endo Clip™ II clip applier has application in many types of endoscopic procedures to achieve occlusion of vessels and other tubular structures and for radiographic markings.

The instrument is primarily indicated for patients undergoing laparoscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures. It can also be used to mark anatomical structures during surgery, and for radiographic marking.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K853650

3 other devices cite the same predicate.

  • K142869Premium Surgiclip IIICovidien · 2014
  • K981645Titanium Hemostatic ClipVitalitec Int'L., Inc. · 1998
  • K972745Titanium Hemostatic ClipEisner USA, Inc. · 1997

More from Covidien

137 FDA decisions under this applicant name. See the company

  • K241486Sofsilk™ Coated Braided Silk SutureCovidien · 2024
  • K240077Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)Covidien · 2024
  • K231934GIA™ Stapler with Tri-Staple™ TechnologyCovidien · 2023
  • K231240MaxTack™ Motorized Fixation DeviceCovidien · 2023
  • K223130Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140…Covidien · 2023

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/K143644 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143644: Premium Surgiclip¿; Endo Clip¿; AcuClip¿.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143644

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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