Surgipro SMPL-01
by Covidien LP
Surgipro SMPL-01 is a Class II device made by Covidien LP, cleared under FDA 510(k) K982575 on 6 Nov 1998 and listed in FDA GUDID since 2 Sep 2015 (UDI-DI 10884521101319), 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 | Number10884521101319 | Date2 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK982575 | Date6 Nov 1998 | StatusActive |
Official records
- AccessGUDID record 10884521101319
- FDA 510(k) database K982575
Across registries
- FDA 510(k) K982575 decided 6 Nov 1998 Active
- FDA GUDID UDI-DI 10884521101319 listed 2 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K982575
- Listed FDA GUDID 10884521101319
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Surgipro
- Generic name
- Extra-gynaecological surgical mesh, composite-polymer
- Model / reference
- SMPL-01
- Primary DI / UDI-DI
- 10884521101319
- 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
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