510(k) K192183 ยท EYB Catheter, Ureteral, Gastro-Urology
RocaTub Ureteral Catheter
| Applicant | Promepal Sam, Monaco, MC |
| Decision | Substantially Equivalent, Apr 23, 2020 |
| Received | Aug 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192183
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.