Medrobotics Corporation
FDA Regulatory Profile
Medrobotics Corporation appears in FDA public data with 2 recalls, 5 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1191-2019, Class II) was initiated on January 25, 2019. Its most recent 510(k) clearance was granted on January 18, 2018.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 5
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1191-2019 | Class II | Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex | January 25, 2019 |
| Z-1192-2019 | Class II | Obturator (shortcone), Part number 26114 Product Usage: The obturator is a component of the Flex | January 25, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K172796 | Flex Robotic System and Flex Transabdominal Drive | January 18, 2018 |
| K170453 | Medrobotics Flex Robotic System | October 19, 2017 |
| K172036 | Medrobotics Flex Robotic System | August 3, 2017 |
| K162330 | Flex Robotic System and Flex Colorectal Drive | May 4, 2017 |
| K150776 | Medrobotics Flex System | July 17, 2015 |