Cleared Traditional

K162608 - ClariFix Device (FDA 510(k) Clearance)

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

K162608 · Arrinex, Inc. · General & Plastic Surgery device
Feb 2017
Decision
148d
Days
Class 2
Risk

K162608 is an FDA 510(k) clearance for the ClariFix Device. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Arrinex, Inc. (Redwood City, US). The FDA issued a Cleared decision on February 14, 2017 after a review of 148 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.

Submission Details

510(k) Number K162608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2016
Decision Date February 14, 2017
Days to Decision 148 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 132d · This submission: 148d
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 20
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K162608.
XSense Cryoablation System with CryoProbes
K260377 · IceCure Medical , Ltd. · Feb 2026
CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01)
K251928 · Medinice S.A. · Feb 2026
Dr. Yglo Skin Tag Remover
K251524 · Theotclab Healthcare B.V. · Jan 2026
Focused Cryotherapy System
K250742 · Focused Cryo, Inc. · Dec 2025
CryoFreeze Wart and Skin Tag Remover
K253000 · Cryosurgery, Inc. · Oct 2025
TargetCool™ (RM-DT02W)
K253114 · Recensmedical, Inc. · Oct 2025