WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022)— 510(k) K032271

Substantially Equivalent

Wartner USA B.V.

FDA 510(k) clearance K032271 for WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022), Substantially Equivalent on 2003-09-10. Applicant: Wartner USA B.V..

Clearance details

Applicant: Wartner USA B.V.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2003-07-23
Decision date: 2003-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond Hill, Ontario, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.