510(k) Report

510(k) · Cleared

Cleared

Vesocclude Ligating Clip

K091060510(k) TraditionalCleared Sep 23, 2009162-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

Vesocclude Medical, LLC · FZP Clip, Implantable

Cleared on Sep 23, 2009 as substantially equivalent to K901303 (Horizon Surgical, Inc., 1990) and 4 other predicates after a 162-day review. Its family tree reaches back 1 generation to 1984.

Decided
Sep 23, 2009
Review
162 days
Class
Class II
Product code
FZP
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K841547 (1984). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestor1990: 1 other ancestor1984: 2 other ancestorsK841547 · Hemoclip Ligating Clips Med/SML · Edward Weck, Inc. · 19841980198519901995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors K841547 · Hemoclip Ligating Clips Med/SML · Edward Weck, Inc. · 19840
  1. Root · 1 generation backK841547 Hemoclip Ligating Clips Med/SMLEdward Weck, Inc. · 1984
  2. This deviceK091060 Vesocclude Ligating ClipVesocclude Medical, LLC · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K841547Hemoclip Ligating Clips Med/SMLEdward Weck, Inc.1984—
0 (this device)K091060Vesocclude Ligating ClipVesocclude Medical, LLC2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198420
199010
199810
FIG. 1 — Lineage of K091060, 1984–2009Source: 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? (6)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K901303Horizon Surgical Ligating and Marking Clip
Summary page 1
…Common Name: Hemostatic Clip, Ligating Clip Classification Name: Vascular Clip B. Predicate Device Teleflex Medical Horizon Ligating Clips (5 lOks; K901303, K9823 13) Teleflex Medical Hemoclip Ligating Clips (5 lOks; K841547, K841548, K841549) Teleflex Medical Atrauclip Ligati…
Horizon Surgical, Inc.1990—
*K982313Horizon Titanium Clips, Horizon Tantalum Clips
Summary page 1
…n Name: Hemostatic Clip, Ligating Clip Classification Name: Vascular Clip B. Predicate Device Teleflex Medical Horizon Ligating Clips (5 lOks; K901303, K9823 13) Teleflex Medical Hemoclip Ligating Clips (5 lOks; K841547, K841548, K841549) Teleflex Medical Atrauclip Ligating Clips (…
Weck Closure Systems19981
*K841547Hemoclip Ligating Clips Med/SML
Summary page 1
…n Name: Vascular Clip B. Predicate Device Teleflex Medical Horizon Ligating Clips (5 lOks; K901303, K9823 13) Teleflex Medical Hemoclip Ligating Clips (5 lOks; K841547, K841548, K841549) Teleflex Medical Atrauclip Ligating Clips (5 10k; K86 1992) C. Device Description Vesocclude ligatin…
Edward Weck, Inc.1984—
*K841548Hemoclip Ligating Clips M/Large
Summary page 1
…ascular Clip B. Predicate Device Teleflex Medical Horizon Ligating Clips (5 lOks; K901303, K9823 13) Teleflex Medical Hemoclip Ligating Clips (5 lOks; K841547, K841548, K841549) Teleflex Medical Atrauclip Ligating Clips (5 10k; K86 1992) C. Device Description Vesocclude ligating clips a…
Edward Weck, Inc.1984—
*K841549Hemoclip Automatic Clips Medium
Summary page 1
…lip B. Predicate Device Teleflex Medical Horizon Ligating Clips (5 lOks; K901303, K9823 13) Teleflex Medical Hemoclip Ligating Clips (5 lOks; K841547, K841548, K841549) Teleflex Medical Atrauclip Ligating Clips (5 10k; K86 1992) C. Device Description Vesocclude ligating clips are perman…
Edward Weck, Inc.1984—
Kept off the family treeK861992FDA’s K861992 is Model 43200A Cardiac Monitor
Our reading of the summary gave K861992, FDA’s number for Model 43200A Cardiac Monitor (Hewlett-Packard Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Teleflex Medical Atrauclip Ligating Clips”. Kept off the family tree.
Summary page 1
…Clips (5 lOks; K901303, K9823 13) Teleflex Medical Hemoclip Ligating Clips (5 lOks; K841547, K841548, K841549) Teleflex Medical Atrauclip Ligating Clips (5 10k; K86 1992) C. Device Description Vesocclude ligating clips are permanent implant, non-absorbable, sterile, surgical clips made fr…
Hewlett-Packard Co.1986—

Also cleared against K901303: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • 1 of the 5 ancestors has a recall of any class.
  • 1 other device also cites its predicate K901303.

How does its category compare?

All FZP devices

FZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?

Vesocclude ligating clips are intended for use in procedures involving vessels or anatomic structures for which the user determines ligating clips are the best choice. Users should select the size and amount of the clips based on upon their experience, judgment, and needs.

Indications for use as stated in the FDA summary.

Also cleared against K901303

1 other device cites the same predicate.

  • K230966angiOCCLUDE Ligating ClipsA2 Medical Systems, LLC · 2023

More from Vesocclude Medical, LLC

2 FDA decisions under this applicant name. See the company

  • K152082Vesocclude Polymer Ligating ClipVesocclude Medical, LLC · 2016

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/K091060 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091060: Vesocclude Ligating Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091060

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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