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CL8903

by Medtronic PS Medical

CL8903 is a scalp wound clip (FDA Class II; FDA product code HBO, Clip, Scalp) made by Medtronic PS Medical, cleared under FDA 510(k) K050044 on 7 Feb 2005 and listed in FDA GUDID since 12 Sep 2020 (UDI-DI 00721902371592), active as of 22 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

510(k) K050044

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00721902371592 UDI-DI Date12 Sep 2020ListedStatusListed 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
  • FDA GUDID UDI-DI 00721902371592 listed 12 Sep 2020 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

4 dated events

  1. Cleared FDA 510(k) K050044
  2. Recall initiated FDA recalls Z-0622-2018
  3. Recall initiated FDA recalls Z-3212-2018
  4. Listed FDA GUDID 00721902371592

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Scalp wound clip
Model / reference
CL8903
Primary DI / UDI-DI
00721902371592
510(k) Number
FDA product code
HBO
GMDN term
Scalp wound clip
Device class
Class II
Regulation number
882.4150
GUDID distribution status
In Commercial Distribution

Related devices

Category: Scalp wound clip

Cleared under the same submission (K050044)

and 4 more cleared under K050044

Similar devices

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

Other devices from Medtronic PS Medical

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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)