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Auto Suture Disp. Endoscopic Surg. Clip Applier

by United States Surgical, A Division of Tyco Healthc

510(k) K883018

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 NumberK883018 Date3 Aug 1988ClearedStatusActive

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  • Withdrawn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)

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, 19 Sep 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 Disposable Endoscopic Surgical Clip Applier is a surgical device classified as a clip, implantable, designed for endoscopic procedures. It applies surgical clips to tissues, facilitating tissue approximation, occlusion, or ligation during minimally invasive surgeries.

This device is intended for single-use in endoscopic surgical settings and has received FDA 510(k) clearance under the product code FZP (Clip, Implantable). It falls under regulation 878.4300 and was reviewed by the Surgical Devices Panel (SU). The device is non-sterile when supplied and must be sterilized prior to use.

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