Flex 25386
Flex 25386 is a Class II device made by Medrobotics Corporation, cleared under FDA 510(k) K150776 on 17 Jul 2015 and listed in FDA GUDID since 1 Jul 2019 (UDI-DI 00850190004193), 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 | Number00850190004193 | Date1 Jul 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK150776 | Date17 Jul 2015 | StatusActive |
Official records
- AccessGUDID record 00850190004193
- FDA 510(k) database K150776
Across registries
- FDA 510(k) K150776 decided 17 Jul 2015 Active
- FDA GUDID UDI-DI 00850190004193 listed 1 Jul 2019 Listed
Timeline
- Cleared FDA 510(k) K150776
- Listed FDA GUDID 00850190004193
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Flex
- Generic name
- Robotic surgical telemanipulation system
- Model / reference
- 25386
- Primary DI / UDI-DI
- 00850190004193
- 510(k) Number
- FDA product code
- EOB
- GMDN term
- Robotic surgical telemanipulation system
- Device class
- Class II
- Regulation number
- 874.4760
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Robotic surgical arm system.