Flex 50083
Flex 50083 is a Class II device made by Medrobotics Corporation, cleared under FDA 510(k) K140662 on 11 Jun 2014 and listed in FDA GUDID since 7 Jan 2019 (UDI-DI 00850190004162), 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 | Number00850190004162 | Date7 Jan 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140662 | Date11 Jun 2014 | StatusActive |
Official records
- AccessGUDID record 00850190004162
- FDA 510(k) database K140662
Across registries
- FDA 510(k) K140662 decided 11 Jun 2014 Active
- FDA GUDID UDI-DI 00850190004162 listed 7 Jan 2019 Listed
Timeline
- Cleared FDA 510(k) K140662
- Listed FDA GUDID 00850190004162
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Flex
- Generic name
- Laser beam delivery unit holder
- Model / reference
- 50083
- Primary DI / UDI-DI
- 00850190004162
- 510(k) Number
- FDA product code
- GCJ
- GMDN term
- Laser beam delivery unit holder
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
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