# K173323: AnastoClip GC Closure System

- Pathway: 510(k) (Traditional)
- Applicant: LeMaitre Vascular, Inc.
- Decided: Mar 8, 2018 after 139 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933887 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962043: Auto Suture Modified VCS Clip Applier, United States Surgical, A Division of Tyco Healthc (1996) Summary page 4.

## Recalls of this device
- Jun 19, 2018 · Class II · Z-3042-2018: The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distributed in the United

## Indications for use
The AnastoClip GC is intended for use in the creation of everting anastomoses in blood vessels and other small tubular structures when tissue penetration is desired. The Applier is also intended for approximation of dural tissue/ durotomies following open craniotomy and open spinal laminectomy procedures.

Source page: https://510kreport.com/device/K173323
Methodology: https://510kreport.com/methodology