510(k) K201815 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Dornier MAGELLAN Ureteral Access Sheath
| Applicant | Dornier Medtech America, Inc., Kennesaw GA, US |
| Decision | Substantially Equivalent, Nov 20, 2020 |
| Received | Jul 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201815
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.