BIOPSY FORCEP (NON-ELECTRIC)— 510(k) K896147

Substantially Equivalent

Portlyn Corp.

FDA 510(k) clearance K896147 for BIOPSY FORCEP (NON-ELECTRIC), Substantially Equivalent on 1990-04-16. Applicant: Portlyn Corp..

Clearance details

Applicant: Portlyn Corp.
Product code: Code FCL
Advisory panel: Gastroenterology, Urology
Date received: 1989-10-23
Decision date: 1990-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moultonboro, NH, 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.