Cleared Special

Verruca-Freeze H (K243454) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K243454 · Cryosurgery, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
26d
Days
Class 2
Risk

K243454 is an FDA 510(k) clearance for the Verruca-Freeze H. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Cryosurgery, Inc. (Nashville, US). The FDA issued a Cleared decision on December 3, 2024 after a review of 26 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cryosurgery, Inc. devices

Submission Details

510(k) Number K243454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2024
Decision Date December 03, 2024
Days to Decision 26 days
Submission Type Special
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
89d faster than avg
Panel avg: 115d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 64
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K243454.
CryoFreeze Wart and Skin Tag Remover
K243487 · Cryosurgery, Inc. · Mar 2025
Co-Ablation System with Sterile Co-Ablation Probe
K243042 · Hygea Medical Technology Co., Ltd. · Jan 2025
Advanced Cryo Wart Remover
K242288 · Medical Brands Laboratories B.V. · Jan 2025
Compound W Skin Tag Remover
K242803 · Medtech Products, Inc. · Nov 2024
Freeze Point & Private Label Versions
K242625 · Cryoconcepts LP · Oct 2024
IceSeed 1.5 CX Straight Needle (H7493968333170)
K243245 · Boston Scientific Corp · Oct 2024