510(k) K212819 ยท FCG Biopsy Needle
Disposable Biopsy Refill Needle
| Applicant | Suzhou Leapmed Healthcare Corporation, Suzhou, CN |
| Decision | Substantially Equivalent, Jul 6, 2022 |
| Received | Sep 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212819
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.