510(k) K152989 ยท KNW Instrument, Biopsy
Mammotome revolve Dual Vacuum Assist Biopsy System
| Applicant | Devicor Medical Products, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Feb 25, 2016 |
| Received | Oct 13, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152989
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2017 | Devicor Medical Products Inc Mammotome Revolve Dual Vacuum Assist Biopsy
System
The device is used to sample breast tissue that has been identified as suspicious under imaging guidance Terminated |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.