K861876

Substantially Equivalent

CRANIO BLADES AND WIRE PASS DRILL

Applicant: New England Surgical Instrument Corp.
Product code: GFA
Advisory panel: General, Plastic Surgery
Date received: 1986-05-15
Decision date: 1986-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

Adverse events under product code GFA

product code GFA

Death: 2
Injury: 140
Malfunction: 2,337
Total: 2,479

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.