Relimesh PEP1418-O
by Herniamesh
Relimesh PEP1418-O is a Class II device made by Herniamesh, cleared under FDA 510(k) K081327 on 19 Jun 2008 and listed in FDA GUDID since 12 Aug 2016 (UDI-DI 18032919891560), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number18032919891560 | Date12 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK081327 | Date19 Jun 2008 | StatusActive |
Official records
- AccessGUDID record 18032919891560
- FDA 510(k) database K081327
Across registries
- FDA 510(k) K081327 decided 19 Jun 2008 Active
- FDA GUDID UDI-DI 18032919891560 listed 12 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K081327
- Listed FDA GUDID 18032919891560
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Relimesh
- Generic name
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
- Model / reference
- PEP1418-O
- Primary DI / UDI-DI
- 18032919891560
- 510(k) Number
- FDA product code
- FTL
- GMDN term
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 878.3300
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable.