EnCor EnCompass Breast Biopsy and Tissue Removal System— 510(k) K252681

Substantially Equivalent

Bard Peripheral Vascular, Inc.

FDA 510(k) clearance K252681 for EnCor EnCompass Breast Biopsy and Tissue Removal System, Substantially Equivalent on 2025-12-12. Applicant: Bard Peripheral Vascular, Inc..

Clearance details

Applicant: Bard Peripheral Vascular, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2025-08-25
Decision date: 2025-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.