510(k) K230801 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Pathfinder Endoscope Overtube with Balloon Device
| Applicant | Neptune Medical, Inc., Burlingame CA, US |
| Decision | Substantially Equivalent, Jul 28, 2023 |
| Received | Mar 23, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230801
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.