510(k) K163052 ยท KNW Instrument, Biopsy
Brevera Biopsy System with Corlumina Imaging Technology
| Applicant | Hologic, Inc., Malborough MA, US |
| Decision | Substantially Equivalent, Mar 29, 2017 |
| Received | Nov 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163052
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2026 | Hologic, Inc Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. Open, Classified |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.