Cleared Traditional

Histofreezer V (K240106) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240106 · Cryoconcepts LP · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
146d
Days
Class 2
Risk

K240106 is an FDA 510(k) clearance for the Histofreezer V. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Cryoconcepts LP (Easton, US). The FDA issued a Cleared decision on June 10, 2024 after a review of 146 days - within the typical 510(k) review window.

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 Cryoconcepts LP devices

Submission Details

510(k) Number K240106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2024
Decision Date June 10, 2024
Days to Decision 146 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
31d slower than avg
Panel avg: 115d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K240106.
Celsio Flexible Cryocatheter System
K240776 · Endocision Technologies, Inc. · Sep 2024
C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
K240457 · Pentax of America, Inc. · Jul 2024
XSense Cryoablation System with Cryoprobes
K240892 · IceCure Medical , Ltd. · Jun 2024
ICEfx Cryoablation System (FPRCH8000-02)
K234002 · Boston Scientific · Mar 2024
Verruca-Freeze® H
K233347 · Cryosurgery, Inc. · Dec 2023
CryoThin™ Surgical System and Accessories
K231661 · Medinux (Tianjin) Technologies Co., Ltd. · Nov 2023