Permacol P150510
Permacol P150510 is a Class II device made by Sofradim Production, cleared under FDA 510(k) K120605 on 18 May 2012 (1 earlier submission) and listed in FDA GUDID since 22 Oct 2015 (UDI-DI 10884523000146), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | Number10884523000146 | Date22 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK120605 | Date18 May 2012 | StatusActive |
Official records
- AccessGUDID record 10884523000146
- FDA 510(k) database K120605
- FDA 510(k) database K992556
Across registries
- FDA 510(k) K120605 decided 18 May 2012 Active
- FDA GUDID UDI-DI 10884523000146 listed 22 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K992556
- Cleared FDA 510(k) K120605
- Listed FDA GUDID 10884523000146
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Permacol
- Generic name
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
- Model / reference
- P150510
- Primary DI / UDI-DI
- 10884523000146
- FDA product code
- FTM
- GMDN term
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
- Device class
- Class II
- Regulation number
- 878.3300
- GUDID distribution status
- Not in Commercial Distribution
- Size
- Depth — 1.5 MillimeterLength — 5 CentimeterWidth — 10 Centimeter
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