510(k) K173400 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
ORISE Tissue Retractor System
| Applicant | Boston Scientific, Marlboro MA, US |
| Decision | Substantially Equivalent, Feb 9, 2018 |
| Received | Oct 31, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173400
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.