Surgistar 191105
Surgistar 191105 is a Class I device made by Surgistar Inc., cleared under FDA 510(k) K961524 on 16 May 1996 and listed in FDA GUDID since 6 Jun 2016 (UDI-DI 00878799007742), 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 | Number00878799007742 | Date6 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK961524 | Date16 May 1996 | StatusActive |
Official records
- AccessGUDID record 00878799007742
- FDA 510(k) database K961524
Across registries
- FDA 510(k) K961524 decided 16 May 1996 Active
- FDA GUDID UDI-DI 00878799007742 listed 6 Jun 2016 Listed
Timeline
- Cleared FDA 510(k) K961524
- Listed FDA GUDID 00878799007742
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Surgistar
- Generic name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
- Model / reference
- 191105
- Primary DI / UDI-DI
- 00878799007742
- 510(k) Number
- FDA product code
- HMX
- GMDN term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
- Device class
- Class I
- Regulation number
- 886.4350
- GUDID distribution status
- In Commercial Distribution
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