510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Horizon Titanium Clips, Horizon Tantalum Clips

K982313510(k) TraditionalCleared Aug 10, 199840-day reviewClass II21 CFR 878.4300Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Weck Closure Systems · FZP Clip, Implantable

Cleared on Aug 10, 1998 after a 40-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 15 later devices descend from it. It has been recalled once.

Decided
Aug 10, 1998
Review
40 days
Class
Class II
Product code
FZP
Recalls
1
Predicates
0

15 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2023: 2 descendants cleared2009: 1 descendant cleared2005: 1 descendant cleared2020: 1 descendant cleared2006: 1 descendant cleared2011: 1 descendant cleared2019: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant cleared2024: 3 descendants cleared2025: 1 descendant cleared1995200020052010201520202025
  1. This deviceK982313 Horizon Titanium Clips, Horizon Tantalum ClipsWeck Closure Systems · 1998
  2. Descendant · cites it directly · 7 of its ownK200166 Mirus Ligating Clip, Mirus Ligating Clip ApplierM/s. Meril Endo Surgery Private Limited. · 2020
  3. Descendant · 2 generations on · 6 of its ownK212127 PicocaremajestyWontech Co., Ltd. · 2022
  4. Descendant · 3 generations on · 2 of its ownK233018 PICOSECOND Nd:YAG Laser SystemIds, Ltd. · 2023
  5. Descendant · 3 generations on · 1 of its ownK233007 Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc. · 2024
  6. Descendant · cites it directly · 1 of its ownK132658 Hemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips…Teleflex Medical · 2013 · Recalled

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12009: 12011: 12013: 12019: 12020: 12022: 12023: 22024: 32025: 12026: 1
2005high 3 (2024) · low 0 (2007)2026

Most influential descendants

Showing 5 of 15 · See all
  • K200166Mirus Ligating Clip, Mirus Ligating Clip ApplierM/s. Meril Endo Surgery Private Limited. · 2020 · cites it directly7descendants
  • K212127PicocaremajestyWontech Co., Ltd. · 2022 · 2 generations on6descendants
  • K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd. · 2023 · 3 generations on2descendants
  • K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc. · 2024 · 3 generations on1descendant
  • K132658Hemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips, Horizon Ligting ClipsTeleflex Medical · 2013 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K982313Horizon Titanium Clips, Horizon Tantalum ClipsWeck Closure Systems1998—
+1K200166Mirus Ligating Clip, Mirus Ligating Clip ApplierM/s. Meril Endo Surgery Private Limited.2020—
+2K212127PicocaremajestyWontech Co., Ltd.2022—
+3K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.2023—
+3K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.2024—
+1K132658Hemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips, Horizon…Teleflex Medical20131

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200910
201110
201310
201910
202010
202210
202320
202430
202510
202610
FIG. 1 — Lineage of K982313, 1998–2026Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K200166Mirus Ligating Clip, Mirus Ligating Clip ApplierM/s. Meril Endo Surgery Private Limited.20207
K132658Hemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips, Horizon Ligting ClipsTeleflex Medical20131
K053255Nexus Ligating ClipMicrosurgical Laboratories,Inc.Dba Wexler Surgical20061
K052018Miltex Ligating ClipMiltex, Inc.20051
K230966angiOCCLUDE Ligating ClipsA2 Medical Systems, LLC20230
K091060Vesocclude Ligating ClipVesocclude Medical, LLC20090

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 8, 2013Class IIZ-2327-2016Error in labelingThe manufacturing and expiration dates are not printed on the blister pack label.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K200166 (M/s. Meril Endo Surgery Private Limited., 2020) has gone furthest, with 7 descendants of its own.

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?

Horizon ligating clips are indicated for procedures involving vessels or anatomic structures where ligating clips are the best choice. Select clip size, type and material based upon experience, judgement and needs.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Weck Closure Systems

6 FDA decisions under this applicant name. See the company

  • K011660Weck Cardiac Pacing WiresWeck Closure Systems · 2001
  • K003337Hem-O-Lok SMX, Model 544220; Hem-O-Lok ML, Model 544230; Hem-O-Lok MLX, Model 544240Weck Closure Systems · 20002 recalls
  • K993157Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model 544240Weck Closure Systems · 19991 recall
  • K982941Hem-O-Lok Model Numbers 523900, 523970Weck Closure Systems · 19981 recall
  • K982944Hem-O-Lock, Model 523935Weck Closure Systems · 1998

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/K982313 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982313: Horizon Titanium Clips, Horizon Tantalum Clips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982313

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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