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GalaFLEX 3D 100042-05

by Tepha, Inc.

GalaFLEX 3D 100042-05 (SH3D05) is a Class II device made by Tepha, Inc., cleared under FDA 510(k) K161092 on 23 Aug 2016 and listed in FDA GUDID since 29 Sep 2020 (UDI-DI 00810054980308), active as of 23 Oct 2026. One FDA recall is 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

1 closed

Documents

510(k) K161092

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 Number00810054980308 UDI-DI Date29 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK161092 Date23 Aug 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161092 decided 23 Aug 2016 Active
  • FDA GUDID UDI-DI 00810054980308 listed 29 Sep 2020 Listed

Recalls

1 recall · FDA

    • Terminated Z-0948-2017 FDA Class II initiated 21 Nov 2016

    Endotoxin values from testing of retains slightly exceeded the established specification.

Timeline

3 dated events

  1. Cleared FDA 510(k) K161092
  2. Recall initiated FDA recalls Z-0948-2017
  3. Listed FDA GUDID 00810054980308

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
GalaFLEX 3D
Generic name
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Model / Ref / Catalog
100042-05, SH3D05
Primary DI / UDI-DI
00810054980308
FDA product code
OOD
GMDN term
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Device class
Class II
Regulation number
878.3300
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe
Size
Length — 21.0 Centimeter
Height — 7.5 Centimeter

Related devices

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

Cleared under the same submission (K161092)

and 2 more cleared under K161092

Similar devices

Other devices filed under FDA product code OOD (Surgical Film).

Other devices from Tepha, Inc.

See all devices from Tepha, Inc. →

Properties

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