PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM— 510(k) K954596

Substantially Equivalent

Promedical , Ltd.

FDA 510(k) clearance K954596 for PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM, Substantially Equivalent on 1995-10-07. Applicant: Promedical , Ltd..

Clearance details

Applicant: Promedical , Ltd.
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 1995-10-03
Decision date: 1995-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wyckoff, NJ, 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.