GXH · Device, Surgical, Cryogenic
Neurology · 21 CFR 882.4250 · Class 2
Overview
| Product Code | GXH |
|---|---|
| Device Name | Device, Surgical, Cryogenic |
| Regulation | 21 CFR 882.4250 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | cryoICE cryoXT cryoablation probe (cryoXT) | AtriCure, Inc. | Apr 10, 2025 | SESE |
| K243677 | iovera° System | Pacira Biosciences, Inc. | Dec 26, 2024 | SESE |
| K243157 | AtriCure cryoICE BOX (ACM) | AtriCure, Inc. | Oct 29, 2024 | SESE |
| 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) | AtriCure, Inc. | Oct 26, 2023 | SESE |
| K220656 | iovera System | Pacira Biosciences, Inc. | May 20, 2022 | SESE |
| K211334 | Iovera System | Pacira Pharmaceuticals, Inc. | Sep 10, 2021 | SESE |
| K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) | AtriCure, Inc. | Dec 23, 2020 | SESE |
| K182565 | AtriCure cryoICE cryoSPHERE cryoablation probe | AtriCure, Inc. | Nov 9, 2018 | SESE |
| K173763 | iovera system | Myoscience, Inc. | Feb 28, 2018 | SESE |
| K180138 | AtriCure cryoICE cryo-ablation probe (CRYO2) | AtriCure, Inc. | Feb 15, 2018 | SESE |
| K161835 | iovera system | Myoscience, Inc. | Mar 24, 2017 | SESE |
| K142866 | Myoscience iovera system | Myoscience, Inc. | Jan 21, 2015 | SESE |
| K142203 | Atricure Cryo Module System; cryoICE cryoablation probe | AtriCure, Inc. | Nov 25, 2014 | SESE |
| K133453 | IOVERA | Myoscience, Inc. | Mar 24, 2014 | SESE |
| K123516 | CRYO-TOUCH IV | Myoscience, Inc. | Jan 10, 2013 | SESE |
| K120415 | CRYO-TOUCH III | Myoscience, Inc. | Jun 22, 2012 | SESE |
| K102021 | CRYO-TOUCH II | Myoscience, Inc. | Sep 17, 2010 | SESE |
| K100447 | MYOSCIENCE CRYO-TOUCH | Myoscience, Inc. | Jun 25, 2010 | SESE |
| K050272 | CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS | Cryomedical Instruments, Ltd. | Mar 24, 2005 | SESE |
| K031482 | 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
