510(k) Report

510(k) · Cleared

Cleared

Anson Refix Vascular and Tissue Clip, Models GF-04-01 and GF-04-02

K032896510(k) TraditionalCleared Mar 17, 2004182-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

Anson Medical, Ltd. · FZP Clip, Implantable

Cleared on Mar 17, 2004 as substantially equivalent to K012317 (Coalescent Surgical, 2001) and 2 other predicates after a 182-day review. Its family tree reaches back 4 generations to 1993.

Decided
Mar 17, 2004
Review
182 days
Class
Class II
Product code
FZP
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K933887 (1993). 6 ancestors in all, the oldest K771412 (1977). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1977: 1 other ancestorK933887 · Implantable Clip · United States Surgical, A Division of Tyco Healthc · 1993K962043 · Auto Suture Modified VCS Clip Applier · United States Surgical, A Division of Tyco Healthc · 1996 · recalledK994160 · Coalescent Surgical Sutured-Clip · Coalescent Surgical · 2000K012317 · Coalescent Surgical U-Clip · Coalescent Surgical · 20011975198019851990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor K012317 · Coalescent Surgical U-Clip · Coalescent Surgical · 2001K994160 · Coalescent Surgical Sutured-Clip · Coalescent Surgical · 2000K962043 · Auto Suture Modified VCS Clip Applier · United States Surgical, A Division of Tyco Healthc · 1996 · recalledK933887 · Implantable Clip · United States Surgical, A Division of Tyco Healthc · 19930
  1. Root · 4 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
  2. 3 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
  3. 2 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
  4. 1 generation backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
  5. This deviceK032896 Anson Refix Vascular and Tissue Clip, Models GF-04-01 and GF-04-02Anson Medical, Ltd. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K933887Implantable ClipUnited States Surgical, A Division of Tyco Healthc1993—
−3K962043Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc19967
−2K994160Coalescent Surgical Sutured-ClipCoalescent Surgical2000—
−1K012317Coalescent Surgical U-ClipCoalescent Surgical2001—
0 (this device)K032896Anson Refix Vascular and Tissue Clip, Models GF-04-01 and GF-04-02Anson Medical, Ltd.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197710
199710
FIG. 1 — Lineage of K032896, 1993–2004Source: 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? (3)

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
*K012317Coalescent Surgical U-Clip
Summary page 1
…to woven graft material for general and vascular surgery. Predicate Devices The predicate device for the Refix TM device is the Coalescent Surgical U-Clip (K012317, K994160 and K971588). The Coalescent U Clip is classified as an Implantable Clip and I)elivery System per 21CFR878.4300 and 21CF…
Coalescent Surgical2001—
*K994160Coalescent Surgical Sutured-Clip
Summary page 1
…woven graft material for general and vascular surgery. Predicate Devices The predicate device for the Refix TM device is the Coalescent Surgical U-Clip (K012317, K994160 and K971588). The Coalescent U Clip is classified as an Implantable Clip and I)elivery System per 21CFR878.4300 and 21CFR878.48o0…
Coalescent Surgical2000—
*K971588Evi Sutured-Clip Applier
Summary page 1
…raft material for general and vascular surgery. Predicate Devices The predicate device for the Refix TM device is the Coalescent Surgical U-Clip (K012317, K994160 and K971588). The Coalescent U Clip is classified as an Implantable Clip and I)elivery System per 21CFR878.4300 and 21CFR878.48o0. Device D…
Elective Vascular Intervention Inc. (Evi)1997—

Also cleared against K012317: 9 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 11 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • 9 other devices also cite its predicate K012317.

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 Anson Refix tissue and vascular clip is intended:

To assist in the creation of anastomoses in blood vessels, grafts, and,

For the surgical approximation of tissue to tissue, or tissue to woven graft material for general and vascular surgery.

Indications for use as stated in the FDA summary.

Also cleared against K012317

9 other devices cite the same predicate.

  • K100593Suture Placement Device and Accessories, Flexible Suture Placement Device and Accessories, Lsi R Series…Lsi Solutions, Inc. · 2010
  • K081082U-Clip Uni-Fire, Model M65Medtronic, Inc. · 2008
  • K062057U-Clip Device, Model NC65Medtronic Vascular · 2006
  • K053252U-Clip Device, Models B140, B160 and B180Medtronic Vascular · 2005
  • K040821Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2004
  • K031623Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 20034 recalls

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/K032896 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032896: Anson Refix Vascular and Tissue Clip, Models GF-04-01 and GF-04-02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032896

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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