Surgistar 8119
Surgistar 8119 is a Class I device made by Surgistar Inc., cleared under FDA 510(k) K923689 on 9 Sep 1992 and listed in FDA GUDID since 7 Jul 2016 (UDI-DI 00878799002709), 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 | Number00878799002709 | Date7 Jul 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK923689 | Date9 Sep 1992 | StatusActive |
Official records
- AccessGUDID record 00878799002709
- FDA 510(k) database K923689
Across registries
- FDA 510(k) K923689 decided 9 Sep 1992 Active
- FDA GUDID UDI-DI 00878799002709 listed 7 Jul 2016 Listed
Timeline
- Cleared FDA 510(k) K923689
- Listed FDA GUDID 00878799002709
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Surgistar
- Generic name
- Manual scalpel blade, single-use
- Model / reference
- 8119
- Primary DI / UDI-DI
- 00878799002709
- 510(k) Number
- FDA product code
- DGX
- GMDN term
- Manual scalpel blade, single-use
- Device class
- Class I
- Regulation number
- 866.5065
- GUDID distribution status
- In Commercial Distribution
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