VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM— 510(k) K002402
Substantially EquivalentMitek Products
FDA 510(k) clearance K002402 for VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM, Substantially Equivalent on 2000-08-31. Applicant: Mitek Products.
Clearance details
- Applicant
- Mitek Products
- Product code
- Code HRX
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Norwood, MA, US
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
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.