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Clip Gun CG8901A

by Medtronic PS Medical

Clip Gun CG8901A is a Class II device made by Medtronic PS Medical, cleared under FDA 510(k) K050044 on 7 Feb 2005 (1 earlier submission) and listed in FDA GUDID since 13 Jun 2016 (UDI-DI 20613994845058), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20613994845058 UDI-DI Date13 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK050044 Date7 Feb 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050044 decided 7 Feb 2005 Active· +1 more in the status table
  • FDA GUDID UDI-DI 20613994845058 listed 13 Jun 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-3212-2018 FDA Class II initiated 3 May 2018

    The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. While the Instructions for Use (IFU) state Do not use if package has been previously opened or damaged , it is possible that the seal breach may go undetected by the user's naked eye.

    • Terminated Z-0622-2018 FDA Class II initiated 20 Dec 2017

    Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.

Timeline

5 dated events

  1. Cleared FDA 510(k) K896723
  2. Cleared FDA 510(k) K050044
  3. Listed FDA GUDID 20613994845058
  4. Recall initiated FDA recalls Z-0622-2018
  5. Recall initiated FDA recalls Z-3212-2018

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Clip Gun
Generic name
Scalp clip applier, single-use
Model / reference
CG8901A
Primary DI / UDI-DI
20613994845058
510(k) Number
FDA product code
HBO
GMDN term
Scalp clip applier, single-use
Device class
Class II
Regulation number
882.4150
GUDID distribution status
In Commercial Distribution

Related devices

Category: Scalp clip applier, single-use

Cleared under the same submission (K050044)

and 4 more cleared under K050044

Cleared under the same submission (K896723)

Similar devices

Other devices filed under FDA product code HBO (CLIP, SCALP).

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See all devices from Medtronic PS Medical →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)