510(k) K212284 ยท KNW Instrument, Biopsy
Disposable Automatic Core Biopsy Instrument
| Applicant | Suzhou Leapmed Healthcare Corporation, Suzhou, CN |
| Decision | Substantially Equivalent, Nov 10, 2021 |
| Received | Jul 21, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212284
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.