Cleared Special

K190356 - ClariFix

K190356 is the FDA 510(k) clearance for ClariFix by Arrinex, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEH) cleared through the Special 510(k) pathway after a 11-day FDA review.

K190356 · Arrinex, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
11d
Days
Class 2
Risk

K190356 is an FDA 510(k) clearance for the ClariFix. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Arrinex, Inc. (Menlo Park, US). The FDA issued a Cleared decision on February 26, 2019 after a review of 11 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 Arrinex, Inc. devices

Submission Details

510(k) Number K190356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2019
Decision Date February 26, 2019
Days to Decision 11 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
104d faster than avg
Panel avg: 115d · This submission: 11d
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 80
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K190356.
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
K190194 · Pentax Medical, A Division of Pentax of America, Inc. · May 2019
CryoLab
K190407 · Cryoconcepts LP · Apr 2019
CryoTouch
K183601 · Cryoconcepts LP · Apr 2019
Frozen C
K182392 · B.M. Tech. Worldwide Co., Ltd. · Oct 2018
IceSphere 1.5 CX Cryoablation Needle
K181741 · Galil Medical , Ltd. · Jul 2018
ICEfx Cryoablation System
K181153 · Galil Medical, Inc. · May 2018