K840354

Substantially Equivalent

MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE

Applicant: Sherwood Medical Co.
Product code: FCG
Advisory panel: Gastroenterology, Urology
Date received: 1984-01-26
Decision date: 1984-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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.