K252681
- 510(k) number
- K252681
- Device name
- EnCor EnCompass Breast Biopsy and Tissue Removal System
- Applicant
- Bard Peripheral Vascular, Inc. AZ · US
- Product code
- KNW — Instrument, Biopsy
- Decision date
- 2025-12-12
- Date received
- 2025-08-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252681.pdf
Official FDA record: K252681
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.