510(k) K161234 ยท KNW Instrument, Biopsy
CASSI II Rotational Core Biopsy System
| Applicant | Scion Medical Technologies, LLC, Newtown Square PA, US |
| Decision | Substantially Equivalent, Aug 3, 2016 |
| Received | May 2, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161234
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.