Wartie Advanced Wart Remover or other proprietary name— 510(k) K151309

Substantially Equivalent

Youmedical Corp BV

FDA 510(k) clearance K151309 for Wartie Advanced Wart Remover or other proprietary name, Substantially Equivalent on 2015-08-14. Applicant: Youmedical Corp BV.

Clearance details

Applicant: Youmedical Corp BV
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2015-05-18
Decision date: 2015-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amsterdam, NL

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.