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Auto Suture VCS Anastomotic Clip Cartridge

by United States Surgical, A Division of Tyco Healthc

510(k) K984438

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK984438 Date7 Jan 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Modified Auto Suture*vcs** Anastomotic**clip Cartridge
510(k) Number
FDA Product Code
FZP
Device Class
Class II
Regulation
21 CFR Part 878.4300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Auto Suture VCS Anastomotic Clip Cartridge is a surgical device classified as a Clip, Implantable (OpenFDA classification). It is designed to secure everted tissue edges during vascular anastomosis by applying titanium implantable clips. These clips are used to attach vascular structures or synthetic vascular prostheses, ensuring stable connections in blood vessels and tubular structures.

This device is intended for use in clinical or operating room settings by surgeons. It is supplied as a single-use, sterile cartridge and is regulated under FDA 510(k) clearance (K984438) as substantially equivalent to existing devices. The cartridge is compatible with the Auto Suture Modified VCS Clip Applier and is available in multiple sizes for various anastomotic applications, including arteriotomies, venotomies, and prosthetic graft attachments.

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