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Implantable Clip

by United States Surgical, A Division of Tyco Healthc 3 variants

510(k) K970793

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 NumberK970793 Date30 Jul 1997ClearedStatusActive

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  • Withdrawn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, 21 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 Implantable Clip is a medical device classified as an implantable clip. It is designed for use in general and plastic surgery procedures.

This device is manufactured by United States Surgical, a division of Tyco Healthcare, and has received FDA 510(k) clearance. It is regulated under the product code FZP and regulation number 878.4300.

Other devices from United States Surgical, A Division of Tyco Healthc

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Questions

AI-generated answers, 21 Sep 2026

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

  • What is the intended use of the Implantable Clip?

    The Implantable Clip is designed for use by clinicians during general and plastic surgery procedures.

  • What is the regulatory status of this device?

    This device has received FDA 510(k) clearance, which indicates that it has been found to be substantially equivalent to other legally marketed devices.

  • Under what classification is this device regulated?

    The Implantable Clip is regulated under product code FZP and regulation number 878.4300, which pertains to implantable clips used in surgery.