Flex 50420
Flex 50420 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 00850190004490), 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 | Number00850190004490 | Date7 Jan 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140662 | Date11 Jun 2014 | StatusActive |
Official records
- AccessGUDID record 00850190004490
- FDA 510(k) database K140662
Across registries
- FDA 510(k) K140662 decided 11 Jun 2014 Active
- FDA GUDID UDI-DI 00850190004490 listed 7 Jan 2019 Listed
Timeline
- Cleared FDA 510(k) K140662
- Listed FDA GUDID 00850190004490
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Flex
- Generic name
- Laparoscopic blunt dissector
- Model / reference
- 50420
- Primary DI / UDI-DI
- 00850190004490
- 510(k) Number
- FDA product code
- GCJ
- GMDN term
- Laparoscopic blunt dissector
- 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).
- GelPort Single Incision Access System by APPLIED MEDICAL RESOURCES CORP.
- Bladeless Trocar UNTR-B0510 by Unimicro Medical Systems (ShenZhen) Co., Ltd.
- Gimmi T.8071.11 II by Gimmi GmbH
- Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447), Non-Network Enabled (72205448) by Smith & Nephew, Inc.
- R-MED Motorized Laparoscopic Handle by R-Med, Inc.
- Integra® CEV538TU by Integra Microfrance
- Gimmi T.8010.52 by Gimmi GmbH
- Integra® CEV9611T1U by Integra Microfrance
- ERAGON MODULAR 8394932 by Richard Wolf GmbH
- Uresil Specimen Retrieval Bag by Uresil Corp.