B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE— 510(k) K950982

Substantially Equivalent

B. Braun of America, Inc.

FDA 510(k) clearance K950982 for B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE, Substantially Equivalent on 1995-04-04. Applicant: B. Braun of America, Inc..

Clearance details

Applicant: B. Braun of America, Inc.
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 1995-03-03
Decision date: 1995-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

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Adverse events under product code FCG

product code FCG

Death: 13
Injury: 576
Malfunction: 1,966
Total: 2,555

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.