VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM— 510(k) K002422
Substantially EquivalentMitek Products
FDA 510(k) clearance K002422 for VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM, Substantially Equivalent on 2000-08-31. Applicant: Mitek Products.
Clearance details
- Applicant
- Mitek Products
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Norwood, MA, US
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.