510(k) K214063 ยท KNW Instrument, Biopsy
Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle
| Applicant | Guangzhou Shengwei Medical Devices Co., Ltd., Conghua City, CN |
| Decision | Substantially Equivalent, Jun 3, 2022 |
| Received | Dec 27, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214063
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.