K262571
- 510(k) number
- K262571
- Device name
- EnCor EnCompass Breast Biopsy and Tissue Removal System
- Applicant
- Bard Peripheral Vascular, Inc. AZ · US
- Product code
- KNW — Instrument, Biopsy
- Decision date
- 2026-08-14
- Date received
- 2026-07-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K262571.pdf
Official FDA record: K262571
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.