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Visu-Lock 5MM Clip Applier

by Gyrx, LLC

510(k) K033161

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 NumberK033161 Date18 Dec 2003ClearedStatusActive

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  • Withdrawn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, 23 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 Visu-Lock 5mm Clip Applier is a clip applier device, classified as a general and plastic surgery device. It is used for implantable clip application.

The device is supplied with a 5mm clip size and is regulated under the product code FZP, with a regulation number of 878.4300. It has been authorized with an FDA 510K clearance, with a decision date of 2003-12-18 and a k-number of K033161.

Other devices from Gyrx, LLC

Questions

AI-generated answers, 23 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 Visu-Lock 5mm Clip Applier used for?

    The Visu-Lock 5mm Clip Applier is used for implantable clip application in general and plastic surgery procedures.

  • What is the clip size of the Visu-Lock 5mm Clip Applier?

    The Visu-Lock 5mm Clip Applier is supplied with a 5mm clip size.

  • Is the Visu-Lock 5mm Clip Applier regulated?

    Yes, the Visu-Lock 5mm Clip Applier is regulated under the product code FZP, with a regulation number of 878.4300, and has been authorized with an FDA 510K clearance.