510(k) K171208 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Trans-anal Introducer
| Applicant | Visionsense, Ltd., Petach Tikva, Hamerkaz, IL |
| Decision | Substantially Equivalent, Feb 5, 2018 |
| Received | Apr 25, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171208
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.