510(k) K210917 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
Single Use Injection Needle
| Applicant | Anrei Medical (Hangzhou) Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, May 28, 2021 |
| Received | Mar 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210917
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.