Skip to content

DuoClipper Titanium Clips

by Scion International, Inc.

510(k) K973652

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 NumberK973652 Date27 Mar 1998ClearedStatusActive

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  • Withdrawn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, 26 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 DuoClipper Titanium Clips is an implantable clip device classified under the General, Plastic Surgery medical specialty. It is a substantially equivalent device cleared through the FDA 510(k) process under product code FZP and regulation number 878.4300.

The device is supplied as a sterile, single-use implantable clip made of titanium. It is intended for use in surgical procedures requiring tissue approximation and is authorized for marketing in the United States under FDA 510(k) clearance K973652.

Other devices from Scion International, Inc.

Questions

AI-generated answers, 26 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 DuoClipper Titanium Clips used for?

    The DuoClipper Titanium Clips is intended for use in surgical procedures requiring tissue approximation, as it is an implantable clip designed to approximate and secure tissues during general and plastic surgery operations.

  • How is the DuoClipper Titanium Clips supplied and is it reusable?

    The device is supplied as a sterile, single-use implantable clip made of titanium, meaning it is intended for one-time use only and must not be reused to ensure patient safety and maintain sterility.

  • What material is the DuoClipper Titanium Clips made from and what is its regulatory classification?

    The DuoClipper Titanium Clips is made of titanium and is classified as a Class II medical device, having been cleared through the FDA 510(k) process under product code FZP and regulation number 878.4300 as substantially equivalent to a predicate device.