510(k) K221085 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
LiNA OperaScope Needle
| Applicant | Lina Medical Aps, Glostrup, DK |
| Decision | Substantially Equivalent, Sep 2, 2022 |
| Received | Apr 13, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221085
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.