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Integra Wound Matrix (Thin)

by Integra Lifesciences Corporation

510(k) K113104

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

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number10381780032410 UDI-DI Date23 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK113104 Date9 Feb 2012ClearedStatusActive

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  • Withdrawn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) · GUDID

Generic Name
Animal-derived wound matrix dressing
Model / Ref / Catalog
54051T
Primary DI / UDI-DI
10381780032410
510(k) Number
FDA Product Code
KGN
GMDN Term
Animal-derived wound matrix dressing
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
Size
Width — 10 Centimeter
Length — 12.5 Centimeter
Length — 5 Inch
Width — 4 Inch

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No