Real Intelligence ROB10406
Real Intelligence ROB10406 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K221224 on 19 Aug 2022 and listed in FDA GUDID since 30 Oct 2023 (UDI-DI 00885556798034), 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 | Number00885556798034 | Date30 Oct 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK221224 | Date19 Aug 2022 | StatusActive |
Official records
- AccessGUDID record 00885556798034
- FDA 510(k) database K221224
Across registries
- FDA 510(k) K221224 decided 19 Aug 2022 Active
- FDA GUDID UDI-DI 00885556798034 listed 30 Oct 2023 Listed
Timeline
- Cleared FDA 510(k) K221224
- Listed FDA GUDID 00885556798034
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Real Intelligence
- Generic name
- Robotic surgical telemanipulation system
- Model / Ref / Catalog
- ROB10406
- Primary DI / UDI-DI
- 00885556798034
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Robotic surgical telemanipulation system
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Robotic surgical arm system.