510(k) K252681 · KNW Instrument, Biopsy
EnCor EnCompass Breast Biopsy and Tissue Removal System
| Applicant | Bard Peripheral Vascular, Inc., Tempe AZ, US |
| Decision | Substantially Equivalent, Dec 12, 2025 |
| Received | Aug 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252681
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Bard Peripheral Vascular Inc EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software Open, Classified |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.