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GORE-TEX Soft Tissue Patch 1305015020

by W. L. Gore & Associates, Inc.

Ref 1305015020Model 1305010020E

GORE-TEX Soft Tissue Patch 1305015020 is a device classified as Class IIb in the EU and Class II in the US made by W. L. Gore & Associates, Inc., registered in EUDAMED on 8 May 2026 (Basic UDI-DI B-00733132600502), cleared under FDA 510(k) K963619 on 25 Oct 1996 and listed in FDA GUDID since 26 Jan 2017 (UDI-DI 00733132600502), withdrawn (EUDAMED), active (FDA 510(k)) as of 23 Oct 2026.

Active Active in United States. Withdrawn in European Union. Also listed in GUDID (US).

CE MDD, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K963619

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00733132600502 Basic UDI-DI 00733132600502UDI-DIDate8 May 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number00733132600502 UDI-DI Date26 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK963619 Date25 Oct 1996DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00733132600502 registered 8 May 2026 Withdrawn
  • FDA 510(k) K963619 decided 25 Oct 1996 Active
  • FDA GUDID UDI-DI 00733132600502 listed 26 Jan 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K963619
  2. Listed FDA GUDID 00733132600502
  3. Registered EUDAMED B-00733132600502

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Withdrawn
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
GORE-TEX® Soft Tissue Patch EUDAMED
GORE-TEX Soft Tissue Patch GUDID
Generic name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Model / Ref / Catalog
1305015020, 1305010020E
Primary DI / UDI-DI
00733132600502
Basic UDI-DI
B-00733132600502
510(k) Number
FDA product code
FTL
EMDN code
P900203 Ptfe surgical meshes
GMDN term
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.3300
EU registration type
Legacy device (under a directive)
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe
Size
Width — 5 Centimeter
Length — 15 Centimeter
Height — 2 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

Cleared under the same submission (K963619)

and 8 more cleared under K963619

Similar devices in this category

Other devices filed under SURGICAL MESHES.

Other devices from W. L. Gore & Associates, Inc.

See all devices from W. L. Gore & Associates, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)