BIOPSY FORCEPS W/NEEDLE M.R. ASSOC.— 510(k) K800963

Substantially Equivalent

Mr Associates, Inc.

FDA 510(k) clearance K800963 for BIOPSY FORCEPS W/NEEDLE M.R. ASSOC., Substantially Equivalent on 1980-05-08. Applicant: Mr Associates, Inc..

Clearance details

Applicant: Mr Associates, Inc.
Product code: Code FCL
Advisory panel: Gastroenterology, Urology
Date received: 1980-04-23
Decision date: 1980-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.