510(k) K210946 ยท KNW Instrument, Biopsy
Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles
| Applicant | Promisemed Hangzhou Meditech Co., Ltd., Hangzhou City, CN |
| Decision | Substantially Equivalent, Aug 12, 2021 |
| Received | Mar 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210946
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.