Bio Protech 9551F
Bio Protech 9551F is a Class II device made by Bio Protech USA, Inc., cleared under FDA 510(k) K073360 on 19 Dec 2007 and listed in FDA GUDID since 5 Jun 2017 (UDI-DI 00817120020739), active as of 22 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 | Number00817120020739 | Date5 Jun 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK073360 | Date19 Dec 2007 | StatusActive |
Official records
- AccessGUDID record 00817120020739
- FDA 510(k) database K073360
Across registries
- FDA 510(k) K073360 decided 19 Dec 2007 Active
- FDA GUDID UDI-DI 00817120020739 listed 5 Jun 2017 Listed
Timeline
- Cleared FDA 510(k) K073360
- Listed FDA GUDID 00817120020739
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bio Protech
- Generic name
- Electrosurgical return electrode, single-use
- Model / reference
- 9551F
- Primary DI / UDI-DI
- 00817120020739
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Electrosurgical return electrode, single-use
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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