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Arthrex® ABS-4054

by Arthrex, Inc.

Arthrex® ABS-4054 is a device classified as Unclassified made by Arthrex, Inc., cleared under FDA 510(k) K130350 on 2 Jul 2013 and listed in FDA GUDID since 15 Feb 2017 (UDI-DI 00888867225367), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K130350

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00888867225367 UDI-DI Date15 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK130350 Date2 Jul 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K130350 decided 2 Jul 2013 Active
  • FDA GUDID UDI-DI 00888867225367 listed 15 Feb 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K130350
  2. Listed FDA GUDID 00888867225367

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Arthrex®
Generic name
Exudate-absorbent dressing, non-gel, antimicrobial
Model / Ref / Catalog
ABS-4054
Primary DI / UDI-DI
00888867225367
510(k) Number
FDA product code
FRO
GMDN term
Exudate-absorbent dressing, non-gel, antimicrobial
Device class
U
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Exudate-absorbent dressing, non-gel, antimicrobial

Cleared under the same submission (K130350)

and 8 more cleared under K130350

Similar devices

Other devices filed under FDA product code FRO (Dressing, wound, drug).

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)