GXH · Class II · 21 CFR 882.4250

FDA Product Code GXH: Device, Surgical, Cryogenic

FDA product code GXH covers surgical cryogenic devices used for neurosurgical ablation.

These probes deliver extreme cold — typically through liquid nitrogen or argon-based systems — to ablate neural tissue for the treatment of movement disorders, chronic pain, and brain tumors. Cryosurgery creates well-defined lesions with sharp margins in brain tissue.

GXH devices are Class II medical devices, regulated under 21 CFR 882.4250 and reviewed by the FDA Neurology panel.

Leading manufacturers include AtriCure, Inc., Myoscience, Inc. and Pacira Biosciences, Inc..

23
Total
23
Cleared
93d
Avg days
1978
Since
Growing category - 3 submissions in the last 2 years vs 1 in the prior period
Review times improving: avg 39d recently vs 101d historically

FDA 510(k) Cleared Device, Surgical, Cryogenic Devices (Product Code GXH)

23 devices
1–23 of 23
Cleared Apr 10, 2025
cryoICE cryoXT cryoablation probe (cryoXT)
K250371
AtriCure, Inc.
Neurology · 59d
Cleared Dec 26, 2024
iovera° System
K243677
Pacira Biosciences, Inc.
Neurology · 29d
Cleared Oct 29, 2024
AtriCure cryoICE BOX (ACM)
K243157
AtriCure, Inc.
Neurology · 29d
Cleared Oct 26, 2023
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP)
K233170
AtriCure, Inc.
Neurology · 29d
Cleared May 20, 2022
iovera System
K220656
Pacira Biosciences, Inc.
Neurology · 74d
Cleared Sep 10, 2021
Iovera System
K211334
Pacira Pharmaceuticals, Inc.
Neurology · 130d
Cleared Dec 23, 2020
AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)
K200697
AtriCure, Inc.
Neurology · 281d
Cleared Nov 09, 2018
AtriCure cryoICE cryoSPHERE cryoablation probe
K182565
AtriCure, Inc.
Neurology · 52d
Cleared Feb 28, 2018
iovera system
K173763
Myoscience, Inc.
Neurology · 79d
Cleared Feb 15, 2018
AtriCure cryoICE cryo-ablation probe (CRYO2)
K180138
AtriCure, Inc.
Neurology · 29d
Cleared Mar 24, 2017
iovera system
K161835
Myoscience, Inc.
Neurology · 262d
Cleared Jan 21, 2015
Myoscience iovera system
K142866
Myoscience, Inc.
Neurology · 112d
Cleared Nov 25, 2014
Atricure Cryo Module System
K142203
AtriCure, Inc.
Neurology · 106d
Cleared Mar 24, 2014
IOVERA
K133453
Myoscience, Inc.
Neurology · 132d
Cleared Jan 10, 2013
CRYO-TOUCH IV
K123516
Myoscience, Inc.
Neurology · 57d
Cleared Jun 22, 2012
CRYO-TOUCH III
K120415
Myoscience, Inc.
Neurology · 133d
Cleared Mar 24, 2005
CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS
K050272
Cryomedical Instruments, Ltd.
Neurology · 48d
Cleared Apr 30, 1986
PAINBLOCKER WA5000
K854334
Wallach Surgical Devices, Inc.
Neurology · 184d
Cleared Aug 12, 1983
CRYOMEDICS NEUROSTAT
K831963
Spembly Medical , Ltd.
Neurology · 56d
Cleared Aug 15, 1978
NEUROSTAT, LLOYD
K781302
Spembly Medical , Ltd.
Neurology · 18d

About Product Code GXH - Regulatory Context

510(k) Submission Activity

23 total 510(k) submissions under product code GXH since 1978, with 23 receiving FDA clearance (average review time: 93 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - GXH Product Code

Recent submissions under GXH have taken an average of 39 days to reach a decision - down from 101 days historically, suggesting improved FDA processing for this classification.

GXH devices are reviewed by the Neurology panel. Browse all Neurology devices →