Medrobotics Corporation
Medical device manufacturer in Raynham, MA.
5510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K172796 | Flex Robotic System and Flex Transabdominal DriveHET · Traditional | 01/18/2018SE |
| K170453 | Medrobotics Flex Robotic SystemEOB · Traditional | 10/19/2017SE |
| K172036 | Medrobotics Flex Robotic SystemFDF · Special | 08/03/2017SE |
| K162330 | Flex Robotic System and Flex Colorectal DriveFDF · Traditional | 05/04/2017SE |
| K150776 | Medrobotics Flex SystemEOB · Traditional | 07/17/2015SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1192-2019 Class II | Obturator (shortcone), Part number 26114 Product Usage: The obturator is a component of…The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators. | 01/25/2019Terminated |
| Z-1191-2019 Class II | Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of…The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators. | 01/25/2019Terminated |