The following data is part of a premarket notification filed by Medrobotics Corporation with the FDA for Flex Robotic System And Flex Transabdominal Drive.
| Device ID | K172796 |
| 510k Number | K172796 |
| Device Name: | Flex Robotic System And Flex Transabdominal Drive |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | MEDROBOTICS CORPORATION 475 Paramount Drive Raynham, MA 02767 |
| Contact | Linda J Varroso |
| Correspondent | Linda J Varroso MEDROBOTICS CORPORATION 475 Paramount Drive Raynham, MA 02767 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-15 |
| Decision Date | 2018-01-18 |
| Summary: | summary |