Product Code: GXH FDA class 2 21 CFR 882.4250

Device, Surgical, Cryogenic

Neurology

The Cryogenic Surgical Device is a neurosurgical instrument that uses extreme cold to destroy or ablate targeted brain tissue, used in procedures such as cryosurgery for tumors or functional neurosurgery for movement disorders. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification to confirm substantial equivalence to a predicate device. The product code is GXH under regulation 21 CFR 882.4250 in the Neurology specialty. It is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

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Years Active

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Basic Information

Product Code: GXH
Device Class: FDA class 2
Regulation Number: 882.4250
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 23 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250371	cryoICE cryoXT cryoablation probe (cryoXT)	Apr 10, 2025	Substantially Equivalent	AtriCure, Inc.
K243677	iovera° System	Dec 26, 2024	Substantially Equivalent	Pacira Biosciences, Inc.
K243157	AtriCure cryoICE BOX (ACM)	Oct 29, 2024	Substantially Equivalent	AtriCure, Inc.
K233170	cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)	Oct 26, 2023	Substantially Equivalent	AtriCure, Inc.
K220656	iovera System	May 20, 2022	Substantially Equivalent	Pacira Biosciences, Inc.
K211334	Iovera System	Sep 10, 2021	Substantially Equivalent	Pacira Pharmaceuticals, Inc.
K200697	AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)	Dec 23, 2020	Substantially Equivalent	AtriCure, Inc.
K182565	AtriCure cryoICE cryoSPHERE cryoablation probe	Nov 09, 2018	Substantially Equivalent	AtriCure, Inc.
K173763	iovera system	Feb 28, 2018	Substantially Equivalent	Myoscience, Inc.
K180138	AtriCure cryoICE cryo-ablation probe (CRYO2)	Feb 15, 2018	Substantially Equivalent	AtriCure, Inc.
K161835	iovera system	Mar 24, 2017	Substantially Equivalent	Myoscience, Inc.
K142866	Myoscience iovera system	Jan 21, 2015	Substantially Equivalent	Myoscience, Inc.
K142203	Atricure Cryo Module System; cryoICE cryoablation probe	Nov 25, 2014	Substantially Equivalent	AtriCure, Inc.
K133453	IOVERA	Mar 24, 2014	Substantially Equivalent	Myoscience, Inc.
K123516	CRYO-TOUCH IV	Jan 10, 2013	Substantially Equivalent	Myoscience, Inc.
K120415	CRYO-TOUCH III	Jun 22, 2012	Substantially Equivalent	Myoscience, Inc.
K102021	CRYO-TOUCH II	Sep 17, 2010	Substantially Equivalent	Myoscience, Inc.
K100447	MYOSCIENCE CRYO-TOUCH	Jun 25, 2010	Substantially Equivalent	Myoscience, Inc.
K050272	CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS	Mar 24, 2005	Substantially Equivalent	Cryomedical Instruments, Ltd.
K031482	CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE	Jul 10, 2003	Substantially Equivalent	Cryomedical Instruemts , Ltd.
K854334	PAINBLOCKER WA5000	Apr 30, 1986	Substantially Equivalent	Wallach Surgical Devices, Inc.
K831963	CRYOMEDICS NEUROSTAT	Aug 12, 1983	Substantially Equivalent	Spembly Medical , Ltd.
K781302	NEUROSTAT, LLOYD	Aug 15, 1978	Substantially Equivalent	Spembly Medical , Ltd.