510(k) K123259 ยท KNW Instrument, Biopsy
MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM
| Applicant | Devicor Medical Products, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Nov 15, 2012 |
| Received | Oct 18, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123259
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2016 | Devicor Medical Products Inc Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graph Terminated |
OIJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.