510(k) K221054 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
CORE-INJECTOR
| Applicant | Incore Co., Ltd., Daegu, KR |
| Decision | Substantially Equivalent, Dec 21, 2022 |
| Received | Apr 11, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221054
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.