EMC FLEXIBLE BIOPSY FORCEPS— 510(k) K941816

Substantially Equivalent

Enterprise Medical Corp.

FDA 510(k) clearance K941816 for EMC FLEXIBLE BIOPSY FORCEPS, Substantially Equivalent on 1994-07-13. Applicant: Enterprise Medical Corp..

Clearance details

Applicant: Enterprise Medical Corp.
Product code: Code FCL
Advisory panel: Gastroenterology, Urology
Date received: 1994-04-13
Decision date: 1994-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greensboro, NC, US

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Adverse events under product code FCL

product code FCL

Death: 5
Total: 5

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.