GalaFLEX 3D 100042-02
by Tepha, Inc.
GalaFLEX 3D 100042-02 (SH3D02) 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 00810054980278), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00810054980278 | Date29 Sep 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK161092 | Date23 Aug 2016 | StatusActive |
Official records
- AccessGUDID record 00810054980278
- FDA 510(k) database K161092
Across registries
- FDA 510(k) K161092 decided 23 Aug 2016 Active
- FDA GUDID UDI-DI 00810054980278 listed 29 Sep 2020 Listed
Recalls
-
- Terminated Z-0948-2017
Endotoxin values from testing of retains slightly exceeded the established specification.
Timeline
- Cleared FDA 510(k) K161092
- Recall initiated FDA recalls Z-0948-2017
- Listed FDA GUDID 00810054980278
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- GalaFLEX 3D
- Generic name
- Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
- Model / Ref / Catalog
- 100042-02, SH3D02
- Primary DI / UDI-DI
- 00810054980278
- 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
- Height — 5.3 CentimeterLength — 15.5 Centimeter
Similar devices
Other devices filed under FDA product code OOD (Surgical Film).