Surgipro SPM-35
by Covidien LP
Surgipro SPM-35 is a Class II device made by Covidien LP, cleared under FDA 510(k) K915526 on 29 May 1992 and listed in FDA GUDID since 2 Sep 2015 (UDI-DI 10884521101364), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10884521101364 | Date2 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK915526 | Date29 May 1992 | StatusActive |
Official records
- AccessGUDID record 10884521101364
- FDA 510(k) database K915526
Across registries
- FDA 510(k) K915526 decided 29 May 1992 Active
- FDA GUDID UDI-DI 10884521101364 listed 2 Sep 2015 Listed
Recalls
-
- Terminated Z-1009-2011
Sterility compromised due to breach in sterile barrier
Timeline
- Cleared FDA 510(k) K915526
- Recall initiated FDA recalls Z-1009-2011
- Listed FDA GUDID 10884521101364
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- Withdrawn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
- SPM-35
- Primary DI / UDI-DI
- 10884521101364
- 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
- Size
- Length — 3 Inch
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