510(k) K001146 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
GENYX FLEXIBLE INJECTION NEEEDLE
| Applicant | Geny Medical, Inc., Aliso Viejo CA, US |
| Decision | Substantially Equivalent, Jun 30, 2000 |
| Received | Apr 10, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001146
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.