510(k) K252247 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)
| Applicant | Olympus Medical Systems Corporation, Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Oct 16, 2025 |
| Received | Jul 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252247
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.