Flex 50644
Flex 50644 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 00850190004681), 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 | Number00850190004681 | Date7 Jan 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140662 | Date11 Jun 2014 | StatusActive |
Official records
- AccessGUDID record 00850190004681
- FDA 510(k) database K140662
Across registries
- FDA 510(k) K140662 decided 11 Jun 2014 Active
- FDA GUDID UDI-DI 00850190004681 listed 7 Jan 2019 Listed
Timeline
- Cleared FDA 510(k) K140662
- Listed FDA GUDID 00850190004681
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- Withdrawn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
- 50644
- Primary DI / UDI-DI
- 00850190004681
- 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
Similar devices
Other devices filed under FDA product code GCJ (Laparoscope, General & Plastic Surgery).
- SCANLAN® 9009-228 by SCANLAN INTERNATIONAL INC
- Gimmi T.0510.11 by Gimmi GmbH
- Integra® CEV9660T1U by Integra Microfrance
- LAPAROSCOPIC BALLOON RETRACTOR by Origin Medsystems, Inc.
- ERAGON MODULAR 8393285 8393.285 by Richard Wolf GmbH
- 021499-10 by Karl Storz SE & CO. KG
- AMCATH DISPOSABLE MICRO SCISSORS by Intl. Medical, Inc.
- KARL STORZ INST. FOR ENDOSCOPIC SELECTIVE PERF. VEIN DISCISSION & PARATIBIAL FASCIOTOMY by Karl Storz Endoscopy-America, Inc.
- ERAGON BIPOLAR 83930035 by Richard Wolf GmbH
- MICROSURGICAL INSTRUMENTS by Mahe-Medizintechnik