Vivosorb 5x7 cm
by Polyganics Innovations B.V.
Vivosorb 5x7 cm (FS01-035/20) is a Class II device made by Polyganics Innovations B.V., cleared under FDA 510(k) K042811 on 8 Nov 2004 and listed in FDA GUDID since 21 Sep 2015 (UDI-DI 08717703990201), 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 | Number08717703990201 | Date21 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK042811 | Date8 Nov 2004 | StatusActive |
Official records
- AccessGUDID record 08717703990201
- FDA 510(k) database K042811
Across registries
- FDA 510(k) K042811 decided 8 Nov 2004 Active
- FDA GUDID UDI-DI 08717703990201 listed 21 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K042811
- Listed FDA GUDID 08717703990201
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vivosorb
- Generic name
- Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
- Model / Ref / Catalog
- 5x7 cm, FS01-035/20
- Primary DI / UDI-DI
- 08717703990201
- 510(k) Number
- FDA product code
- FTL
- GMDN term
- Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
- Device class
- Class II
- Regulation number
- 878.3300
- GUDID distribution status
- In Commercial Distribution
- Size
- Width — 7 CentimeterLength — 5 Centimeter
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