The following data is part of a premarket notification filed by Medrobotics Corporation with the FDA for Medrobotics Flex Robotic System.
| Device ID | K170453 |
| 510k Number | K170453 |
| Device Name: | Medrobotics Flex Robotic System |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | Medrobotics Corporation 475 Paramount Drive Raynham, MA 02767 |
| Contact | John D. Bonasera |
| Correspondent | John D. Bonasera Medrobotics Corporation 475 Paramount Drive Raynham, MA 02767 |
| Product Code | EOB |
| Subsequent Product Code | EOX |
| Subsequent Product Code | GCI |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-15 |
| Decision Date | 2017-10-19 |
| Summary: | summary |