510(k) K180214 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
Repris Bladder Injection System
| Applicant | Uro-1, Inc., Winston Salem NC, US |
| Decision | Substantially Equivalent, May 3, 2018 |
| Received | Jan 25, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180214
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.