CRANIO BLADES AND WIRE PASS DRILL— 510(k) K861876
Substantially EquivalentNew England Surgical Instrument Corp.
FDA 510(k) clearance K861876 for CRANIO BLADES AND WIRE PASS DRILL, Substantially Equivalent on 1986-05-30. Applicant: New England Surgical Instrument Corp..
Clearance details
- Applicant
- New England Surgical Instrument Corp.
- Product code
- Code GFA
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- 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, through . 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.