510(k) K182403 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Peel-Away Introducer
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, May 29, 2019 |
| Received | Sep 4, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182403
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.