WARTNER WART REMOVAL SYSTEM— 510(k) K002714
Substantially EquivalentWartner Medical Products
FDA 510(k) clearance K002714 for WARTNER WART REMOVAL SYSTEM, Substantially Equivalent on 2000-11-28. Applicant: Wartner Medical Products.
Clearance details
- Applicant
- Wartner Medical Products
- Product code
- Code GEH
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brampton, Ontario, CA
Adverse events under product code GEH
product code GEH- Death
- 25
- Injury
- 351
- Malfunction
- 901
- Total
- 1,277
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.