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FORCECORD Implant MWEB5580

by Xiros Ltd

FORCECORD Implant MWEB5580 is a Class II device made by Xiros Ltd, cleared under FDA 510(k) K222978 on 27 Dec 2022 and listed in FDA GUDID since 6 Jul 2026 (UDI-DI 05060267134561), active as of 22 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 22 Oct 2026

Documents

510(k) K222978

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 Number05060267134561 UDI-DI Date6 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK222978 Date27 Dec 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K222978 decided 27 Dec 2022 Active
  • FDA GUDID UDI-DI 05060267134561 listed 6 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K222978
  2. Listed FDA GUDID 05060267134561

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
FORCECORD Implant
Generic name
Surgical support tape, non-bioabsorbable
Model / reference
MWEB5580
Primary DI / UDI-DI
05060267134561
510(k) Number
FDA product code
FTL, QUW, OWX
GMDN term
Surgical support tape, non-bioabsorbable
Device class
Class II
Regulation number
878.3300
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Similar devices

Other devices filed under FDA product code FTL (Mesh, Surgical, Polymeric).

Other devices from Xiros Ltd

See all devices from Xiros Ltd →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)