Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4250](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4250) → GXH — Device, Surgical, Cryogenic # GXH · Device, Surgical, Cryogenic _Neurology · 21 CFR 882.4250 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH ## Overview - **Product Code:** GXH - **Device Name:** Device, Surgical, Cryogenic - **Regulation:** [21 CFR 882.4250](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4250) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **3rd-party reviewable:** yes ## Identification A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 23) Showing 20 most recent of 23 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250371](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K250371.md) | cryoICE cryoXT cryoablation probe (cryoXT) | AtriCure, Inc. | Apr 10, 2025 | SESE | | [K243677](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K243677.md) | iovera° System | Pacira Biosciences, Inc. | Dec 26, 2024 | SESE | | [K243157](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K243157.md) | AtriCure cryoICE BOX (ACM) | AtriCure, Inc. | Oct 29, 2024 | SESE | | [K233170](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K233170.md) | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) | AtriCure, Inc. | Oct 26, 2023 | SESE | | [K220656](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K220656.md) | iovera System | Pacira Biosciences, Inc. | May 20, 2022 | SESE | | [K211334](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K211334.md) | Iovera System | Pacira Pharmaceuticals, Inc. | Sep 10, 2021 | SESE | | [K200697](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K200697.md) | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) | AtriCure, Inc. | Dec 23, 2020 | SESE | | [K182565](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K182565.md) | AtriCure cryoICE cryoSPHERE cryoablation probe | AtriCure, Inc. | Nov 9, 2018 | SESE | | [K173763](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K173763.md) | iovera system | Myoscience, Inc. | Feb 28, 2018 | SESE | | [K180138](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K180138.md) | AtriCure cryoICE cryo-ablation probe (CRYO2) | AtriCure, Inc. | Feb 15, 2018 | SESE | | [K161835](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K161835.md) | iovera system | Myoscience, Inc. | Mar 24, 2017 | SESE | | [K142866](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K142866.md) | Myoscience iovera system | Myoscience, Inc. | Jan 21, 2015 | SESE | | [K142203](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K142203.md) | Atricure Cryo Module System; cryoICE cryoablation probe | AtriCure, Inc. | Nov 25, 2014 | SESE | | [K133453](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K133453.md) | IOVERA | Myoscience, Inc. | Mar 24, 2014 | SESE | | [K123516](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K123516.md) | CRYO-TOUCH IV | Myoscience, Inc. | Jan 10, 2013 | SESE | | [K120415](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K120415.md) | CRYO-TOUCH III | Myoscience, Inc. | Jun 22, 2012 | SESE | | [K102021](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K102021.md) | CRYO-TOUCH II | Myoscience, Inc. | Sep 17, 2010 | SESE | | [K100447](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K100447.md) | MYOSCIENCE CRYO-TOUCH | Myoscience, Inc. | Jun 25, 2010 | SESE | | [K050272](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K050272.md) | CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS | Cryomedical Instruments, Ltd. | Mar 24, 2005 | SESE | | [K031482](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH/K031482.md) | CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE | Cryomedical Instruemts , Ltd. | Jul 10, 2003 | SESE | ## Top Applicants - Myoscience, Inc. — 8 clearances - AtriCure, Inc. — 7 clearances - Pacira Biosciences, Inc. — 2 clearances - Spembly Medical , Ltd. — 2 clearances - Cryomedical Instruemts , Ltd. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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