K880859
Substantially EquivalentSURGICAL BURS
- Applicant
- New England Surgical Instrument Corp.
- Product code
- GFF
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockland, MA, US
Adverse events under product code GFF
product code GFF- Malfunction
- 459
- Other
- 1
- Total
- 460
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.