Advanced Cryo Wart Remover— 510(k) K242288

Substantially Equivalent

Medical Brands Laboratories B.V.

FDA 510(k) clearance K242288 for Advanced Cryo Wart Remover, Substantially Equivalent on 2025-01-21. Applicant: Medical Brands Laboratories B.V..

Clearance details

Applicant: Medical Brands Laboratories B.V.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2024-08-02
Decision date: 2025-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Diemen, 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.