The following data is part of a premarket notification filed by Medrobotics Corporation with the FDA for Flex Robotic System And Flex Colorectal Drive.
| Device ID | K162330 |
| 510k Number | K162330 |
| Device Name: | Flex Robotic System And Flex Colorectal Drive |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | Medrobotics Corporation 475 Paramount Drive Raynham, MD 02767 |
| Contact | John D. Bonasera |
| Correspondent | John D. Bonasera Medrobotics Corporation 475 Paramount Drive Raynham, MD 02767 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-19 |
| Decision Date | 2017-05-04 |
| Summary: | summary |