Cleared Traditional

K031482 - CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE

K031482 is an FDA 510(k) clearance for CRYOSTAR SYSTEM, manufactured by Cryomedical Instruemts , Ltd.. The device is a Class 2 Neurology device with product code GXH cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K031482 · Cryomedical Instruemts , Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
59d
Days
Class 2
Risk

K031482 is an FDA 510(k) clearance for the CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, .... Classified as Device, Surgical, Cryogenic (product code GXH), Class II - Special Controls.

Submitted by Cryomedical Instruemts , Ltd. (Mansfield Woodhouse, Notts, GB). The FDA issued a Cleared decision on July 10, 2003 after a review of 59 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K031482

510(k) Number K031482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2003
Decision Date July 10, 2003
Days to Decision 59 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 149d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K031482.
CRYO-TOUCH II
K102021 · Myoscience, Inc. · Sep 2010
MYOSCIENCE CRYO-TOUCH
K100447 · Myoscience, Inc. · Jun 2010
CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS
K050272 · Cryomedical Instruments, Ltd. · Mar 2005
PAINBLOCKER WA5000
K854334 · Wallach Surgical Devices, Inc. · Apr 1986
CRYOMEDICS NEUROSTAT
K831963 · Spembly Medical , Ltd. · Aug 1983
NEUROSTAT, LLOYD
K781302 · Spembly Medical , Ltd. · Aug 1978
K031482 · CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE
Download PDF FDA Summary Cryomedical Instruemt…