Cleared Special

K102021 - CRYO-TOUCH II

K102021 is an FDA 510(k) clearance for CRYO-TOUCH II, manufactured by Myoscience, Inc.. The device is a Class 2 Neurology device with product code GXH cleared through the Special 510(k) pathway after a 60-day FDA review.

K102021 · Myoscience, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
60d
Days
Class 2
Risk

K102021 is an FDA 510(k) clearance for the CRYO-TOUCH II. Classified as Device, Surgical, Cryogenic (product code GXH), Class II - Special Controls.

Submitted by Myoscience, Inc. (Redwood City, US). The FDA issued a Cleared decision on September 17, 2010 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4250 - the FDA neurology 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.

FDA 510(k) Submission Details - K102021

510(k) Number K102021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2010
Decision Date September 17, 2010
Days to Decision 60 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 149d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

GXH Device Classification - Class 2, Special Controls

Product Code GXH Device, Surgical, Cryogenic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4250
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 Neurology devices follow this clearance model.

Regulatory Peers - GXH Device, Surgical, Cryogenic

All 22
Devices cleared under the same product code (GXH) and FDA review panel - the closest regulatory comparables to K102021.
IOVERA
K133453 · Myoscience, Inc. · Mar 2014
CRYO-TOUCH IV
K123516 · Myoscience, Inc. · Jan 2013
CRYO-TOUCH III
K120415 · Myoscience, Inc. · Jun 2012
MYOSCIENCE CRYO-TOUCH
K100447 · Myoscience, Inc. · Jun 2010
CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS
K050272 · Cryomedical Instruments, Ltd. · Mar 2005
CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE
K031482 · Cryomedical Instruemts , Ltd. · Jul 2003
K102021 · CRYO-TOUCH II
Download PDF FDA Summary Myoscience, Inc.