Cleared Traditional

K173323 - AnastoClip GC Closure System (FDA 510(k) Clearance)

K173323 · LeMaitre Vascular, Inc. · General & Plastic Surgery device

Mar 2018

Decision

139d

Days

Class 2

Risk

K173323 is an FDA 510(k) clearance for the AnastoClip GC Closure System. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).

Submitted by LeMaitre Vascular, Inc. (Burlington, US). The FDA issued a Cleared decision on March 8, 2018, 139 days after receiving the submission on October 20, 2017.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number	K173323 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 20, 2017
Decision Date	March 08, 2018
Days to Decision	139 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF