K252681 is an FDA 510(k) clearance for the EnCor EnCompass™ Breast Biopsy and Tissue Removal System. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on December 12, 2025, 109 days after receiving the submission on August 25, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K252681 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2025 |
| Decision Date | December 12, 2025 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KNW — Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |