FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)— 510(k) K103359

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K103359 for FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK), Substantially Equivalent on 2010-12-27. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2010-11-16
Decision date: 2010-12-27
Decision: Substantially Equivalent
Clearance type: Special
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.