510(k) Report

510(k) · Cleared

Cleared

Vessel Closure Device (VCD177213P)

K260677510(k) TraditionalCleared Sep 17, 2026199-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

Vcd Medical S.R.L. · FZP Clip, Implantable

Cleared on Sep 17, 2026 as substantially equivalent to K140932 (Amsel Medical Corporation, 2015) and 1 other predicate after a 199-day review. Its family tree reaches back 3 generations to 1983.

Decided
Sep 17, 2026
Review
199 days
Class
Class II
Product code
FZP
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K830503 (1983). 5 ancestors in all. No later device cites it as a predicate yet.

  1. Root · 3 generations backK830503 Ligaclip Titanium Ligating ClipETHICON, Inc. · 1983 · Recalled
  2. 2 generations backK032238 Twister Superelastic Ligating Clip and ApplierNeurosel (Medical) Limited · 2003
  3. 1 generation backK140932 Amsel Occluder DeviceAmsel Medical Corporation · 2015
  4. This deviceK260677 Vessel Closure Device (VCD177213P)Vcd Medical S.R.L. · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K830503Ligaclip Titanium Ligating ClipETHICON, Inc.19833
−2K032238Twister Superelastic Ligating Clip and ApplierNeurosel (Medical) Limited2003—
−1K140932Amsel Occluder DeviceAmsel Medical Corporation2015—
0 (this device)K260677Vessel Closure Device (VCD177213P)Vcd Medical S.R.L.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198610
FIG. 1 — Lineage of K260677, 1983–2026Source: 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 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 K254231 Inno-Hook™ Disposable Clip Appliers (Ligating…score 12.6 · 4 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? (2)

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
*K140932Amsel Occluder Device
Summary page 5
…Class II Classification regulation: 21 CFR 878.4300 Product Codes: FZP F. Predicate Device Amsel Occluder Device K140932 (primary predicate) LigaClip 20/20 Multiple Clip Applier K864102 (secondary predicate) G. Device Description The Vessel Closure…
Amsel Medical Corporation2015—
*K864102Ligaclip 20/20* Multiple Clip Applier
Summary page 5
…21 CFR 878.4300 Product Codes: FZP F. Predicate Device Amsel Occluder Device K140932 (primary predicate) LigaClip 20/20 Multiple Clip Applier K864102 (secondary predicate) G. Device Description The Vessel Closure Device (VCD) allows for selective closure of superficial and perfo…
ETHICON, Inc.19864

Also cleared against K140932: 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?

  • The line of descent spans 43 years and passes through 4 companies; a new generation was cleared every 11.6 years on median.
  • 2 of the 5 ancestors have a recall of any class.
  • 1 other device also cites its predicate K140932.

How does its category compare?

All FZP devices

FZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Vessel Closure Device (VCD) is indicated for use in open general surgery and percutaneous procedures on superficial

and perforator venous vessels, when occlusion through clamping by clips is required. A single clip is intended for vessels

within the range of 2.0 and < 7.0 mm in diameter.

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

Cite this page

510(k) Report. “K260677: Vessel Closure Device (VCD177213P).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260677

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026