AnastoClip GC Closure System— 510(k) K173323

Clearance details

Applicant

LeMaitre Vascular, Inc.

Product code

Code FZP

Device class

Class 2

Regulation

21 CFR 878.4300

Advisory panel

General, Plastic Surgery

Date received

2017-10-20

Decision date

2018-03-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Burlington, MA, US

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• K250643 — Disposable Polymer Ligation Clips2025-11-20
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• K212894 — PhasTIPP2022-03-31
• K183513 — XenoSure Dura Biologic Patch2019-06-13
• K152833 — Pruitt F3-S Polyurethane Carotid Shunt2016-01-21
• K143454 — Pruitt F3-S Carotid Shunt2015-08-27
• K142660 — Antegrade LeMills Valvulotome2014-10-17

Death

11

Injury

726

Malfunction

10,830

Other

1

Total

11,568

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-3042-2018 — AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or closing of a vessel with possible intraluminal penetration.Class II·Terminated·LeMaitre Vascular, Inc.·20180619

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173323.