510(k) Report

510(k) · Cleared

Cleared

Vesocclude Polymer Ligating Clip

K152082510(k) TraditionalCleared Feb 26, 2016214-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 Feb 26, 2016 as substantially equivalent to K030311 (Weck, 2003) and 3 other predicates after a 214-day review. Its family tree reaches back 3 generations to 1992.

Decided
Feb 26, 2016
Review
214 days
Class
Class II
Product code
FZP
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K922186 (1992). 6 ancestors in all, the oldest K902108 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor2000: 1 other ancestor1990: 1 other ancestorK922186 · Hem-O-Lok -- Modification · Linvatec Corp. · 1992K982941 · Hem-O-Lok Model Numbers 523900, 523970 · Weck Closure Systems · 1998 · recalledK993157 · Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model 544240 · Weck Closure Systems · 1999 · recalled199019952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors K993157 · Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model 544240 · Weck Closure Systems · 1999 · recalledK982941 · Hem-O-Lok Model Numbers 523900, 523970 · Weck Closure Systems · 1998 · recalledK922186 · Hem-O-Lok -- Modification · Linvatec Corp. · 19920
  1. Root · 3 generations backK922186 Hem-O-Lok -- ModificationLinvatec Corp. · 1992
  2. 2 generations backK982941 Hem-O-Lok Model Numbers 523900, 523970Weck Closure Systems · 1998 · Recalled
  3. 1 generation backK993157 Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer…Weck Closure Systems · 1999 · Recalled
  4. This deviceK152082 Vesocclude Polymer Ligating ClipVesocclude Medical, LLC · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K922186Hem-O-Lok -- ModificationLinvatec Corp.1992—
−2K982941Hem-O-Lok Model Numbers 523900, 523970Weck Closure Systems19981
−1K993157Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model…Weck Closure Systems19991
0 (this device)K152082Vesocclude Polymer Ligating ClipVesocclude Medical, LLC2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
200010
200310
FIG. 1 — Lineage of K152082, 1992–2016Source: 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? (4)

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
*K030311Hem-O-Lok XL Clip
Summary page 4
…1 CFR 878.4300 Product Code: FZP Predicate Device: Teleflex Medical Hem-o-lok® Ligating Clips (K030311, K003337, K993157, K902108) Device Description: The Vesocclude™ ligating clips are non-absorbable, non- active implantable devic…
Weck20031
*K003337Hem-O-Lok SMX, Model 544220; Hem-O-Lok ML, Model 544230; Hem-O-Lok MLX, Model 544240
Summary page 4
….4300 Product Code: FZP Predicate Device: Teleflex Medical Hem-o-lok® Ligating Clips (K030311, K003337, K993157, K902108) Device Description: The Vesocclude™ ligating clips are non-absorbable, non- active implantable devices to be…
Weck Closure Systems20002
*K993157Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model 544240
Summary page 4
…oduct Code: FZP Predicate Device: Teleflex Medical Hem-o-lok® Ligating Clips (K030311, K003337, K993157, K902108) Device Description: The Vesocclude™ ligating clips are non-absorbable, non- active implantable devices to be used for…
Weck Closure Systems19991
*K902108Hem-O-Lok (TM)
Summary page 4
…e: FZP Predicate Device: Teleflex Medical Hem-o-lok® Ligating Clips (K030311, K003337, K993157, K902108) Device Description: The Vesocclude™ ligating clips are non-absorbable, non- active implantable devices to be used for ligation…
Edward Weck, Inc.1990—

Also cleared against K030311: 4 other devices →

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?

  • The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
  • 4 of the 6 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K030311.

How does its category compare?

All FZP devices

FZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?

Intended Use: The Vesocclude Polymer Ligation Clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

Contraindications: Vesocclude polymer ligation clips are not intended for use as a fallopian contraceptive tubal occlusion device. Vesocclude polymer ligation clips are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies.

Indications for use as stated in the FDA summary.

Also cleared against K030311

4 other devices cite the same predicate.

  • K220006angioLOCK Polymer Ligating ClipA2 Medical Systems, LLC · 2022
  • K133202Hem-O-Lok Ligating ClipTeleflex Medical · 2013
  • K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove Section Guide Model…AtriCure, Inc. · 2010
  • K062914Hem-O-Lok Ligation ClipTeleflex Medical · 2006

More from Vesocclude Medical, LLC

2 FDA decisions under this applicant name. See the company

  • K091060Vesocclude Ligating ClipVesocclude Medical, LLC · 2009

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/K152082 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152082: Vesocclude Polymer Ligating Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152082

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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