Cleared Traditional

K242288 - Advanced Cryo Wart Remover

K242288 is an FDA 510(k) clearance for Advanced Cryo Wart Remover, manufactured by Medical Brands Laboratories B.V.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K242288 · Medical Brands Laboratories B.V. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
172d
Days
Class 2
Risk

K242288 is an FDA 510(k) clearance for the Advanced Cryo Wart Remover. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Medical Brands Laboratories B.V. (Diemen, NL). The FDA issued a Cleared decision on January 21, 2025 after a review of 172 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4350 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Brands Laboratories B.V. devices

FDA 510(k) Submission Details - K242288

510(k) Number K242288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2024
Decision Date January 21, 2025
Days to Decision 172 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 115d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEH Device Classification - Class 2, Special Controls

Product Code GEH Unit, Cryosurgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEH Unit, Cryosurgical, Accessories

All 119
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K242288.
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K243454 · Cryosurgery, Inc. · Dec 2024
Compound W Skin Tag Remover
K242803 · Medtech Products, Inc. · Nov 2024
Freeze Point & Private Label Versions
K242625 · Cryoconcepts LP · Oct 2024