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

Name: FDA 510(k) clearance K950982
Creator: U.S. Food and Drug Administration
Published: 1995-04-04

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.. Device class: 2.

Clearance details

Applicant: B. Braun of America, Inc.
Product code: Code FCG
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1995-03-03
Decision date: 1995-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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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.