510(k) K162330 ยท FDF Colonoscope And Accessories, Flexible/Rigid
Flex Robotic System and Flex Colorectal Drive
| Applicant | Medrobotics Corporation, Raynham MD, US |
| Decision | Substantially Equivalent, May 4, 2017 |
| Received | Aug 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162330
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2019 | Medrobotics Corporation 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 in Terminated |
FDF | None listed |
| Jan 25, 2019 | Medrobotics Corporation 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 in Terminated |
FDF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.