EyeRSurgN 10010
EyeRSurgN 10010 is a Class II device made by Smartsurgn Inc., cleared under FDA 510(k) K213943 on 29 Nov 2022 and listed in FDA GUDID since 16 Oct 2023 (UDI-DI G465100100), 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 | NumberG465100100 | Date16 Oct 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213943 | Date29 Nov 2022 | StatusActive |
Official records
- FDA 510(k) database K213943
Across registries
- FDA 510(k) K213943 decided 29 Nov 2022 Active
- FDA GUDID UDI-DI G465100100 listed 16 Oct 2023 Listed
Timeline
- Cleared FDA 510(k) K213943
- Listed FDA GUDID G465100100
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EyeRSurgN
- Generic name
- Endoscopic video image processing unit
- Model / reference
- 10010
- Primary DI / UDI-DI
- G465100100, E30000019
- 510(k) Number
- FDA product code
- OWN
- GMDN term
- Endoscopic video image processing unit
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
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