Parietene DS PPDS1510
Parietene DS PPDS1510 is a Class II device made by Sofradim Production, cleared under FDA 510(k) K163212 on 29 Jun 2017 and listed in FDA GUDID since 15 Dec 2017 (UDI-DI 10884521553453), 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 | Number10884521553453 | Date15 Dec 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163212 | Date29 Jun 2017 | StatusActive |
Official records
- AccessGUDID record 10884521553453
- FDA 510(k) database K163212
Across registries
- FDA 510(k) K163212 decided 29 Jun 2017 Active
- FDA GUDID UDI-DI 10884521553453 listed 15 Dec 2017 Listed
Timeline
- Cleared FDA 510(k) K163212
- Listed FDA GUDID 10884521553453
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Parietene DS
- Generic name
- Extra-gynaecological surgical mesh, composite-polymer
- Model / reference
- PPDS1510
- Primary DI / UDI-DI
- 10884521553453
- 510(k) Number
- FDA product code
- FTL
- GMDN term
- Extra-gynaecological surgical mesh, composite-polymer
- Device class
- Class II
- Regulation number
- 878.3300
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Size
- Width — 15 CentimeterLength — 10 Centimeter
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