510(k) K192498 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
Single Use Injector
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Apr 28, 2020 |
| Received | Sep 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192498
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.