Medrobotics Corporation
Raynham, MA, US
Medrobotics Corporation appears in FDA device records in Raynham, MA. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Medrobotics Corporation between 2015 and 2018. The busiest year on record is 2017, with 3. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2017 | 3 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K172796 | Flex Robotic System and Flex Transabdominal Drive | HET | Substantially Equivalent | |
| K170453 | Medrobotics Flex Robotic System | EOB | Substantially Equivalent | |
| K172036 | Medrobotics Flex Robotic System | FDF | Substantially Equivalent | |
| K162330 | Flex Robotic System and Flex Colorectal Drive | FDF | Substantially Equivalent | |
| K150776 | Medrobotics Flex System | EOB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1192-2019 | Obturator (shortcone), Part number 26114 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (e22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (e22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery. | The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators. | Class II | Terminated | |
| Z-1191-2019 | Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (e22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (e22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery. | The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain