FDA Product Code
FDA Product Code GXH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4250
510(k) Clearances — 23 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250371 | cryoICE cryoXT cryoablation probe (cryoXT) | AtriCure, Inc. | 2025-04-10 | Traditional | PDF ↗ |
| K243677 | iovera° System | Pacira Biosciences, Inc. | 2024-12-26 | Special | PDF ↗ |
| K243157 | AtriCure cryoICE BOX (ACM) | AtriCure, Inc. | 2024-10-29 | Special | PDF ↗ |
| 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. | 2023-10-26 | Special | PDF ↗ |
| K220656 | iovera System | Pacira Biosciences, Inc. | 2022-05-20 | Special | PDF ↗ |
| K211334 | Iovera System | Pacira Pharmaceuticals, Inc. | 2021-09-10 | Special | PDF ↗ |
| K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) | AtriCure, Inc. | 2020-12-23 | Traditional | PDF ↗ |
| K182565 | AtriCure cryoICE cryoSPHERE cryoablation probe | AtriCure, Inc. | 2018-11-09 | Special | PDF ↗ |
| K173763 | iovera system | Myoscience, Inc. | 2018-02-28 | Traditional | PDF ↗ |
| K180138 | AtriCure cryoICE cryo-ablation probe (CRYO2) | AtriCure, Inc. | 2018-02-15 | Special | PDF ↗ |
| K161835 | iovera system | Myoscience, Inc. | 2017-03-24 | Traditional | PDF ↗ |
| K142866 | Myoscience iovera system | Myoscience, Inc. | 2015-01-21 | Traditional | PDF ↗ |
| K142203 | Atricure Cryo Module System; cryoICE cryoablation probe | AtriCure, Inc. | 2014-11-25 | Traditional | PDF ↗ |
| K133453 | IOVERA | Myoscience, Inc. | 2014-03-24 | Traditional | PDF ↗ |
| K123516 | CRYO-TOUCH IV | Myoscience, Inc. | 2013-01-10 | Traditional | PDF ↗ |
| K120415 | CRYO-TOUCH III | Myoscience, Inc. | 2012-06-22 | Traditional | PDF ↗ |
| K102021 | CRYO-TOUCH II | Myoscience, Inc. | 2010-09-17 | Special | PDF ↗ |
| K100447 | MYOSCIENCE CRYO-TOUCH | Myoscience, Inc. | 2010-06-25 | Traditional | PDF ↗ |
| K050272 | CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS | Cryomedical Instruments, Ltd. | 2005-03-24 | Traditional | PDF ↗ |
| K031482 | CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE | Cryomedical Instruemts , Ltd. | 2003-07-10 | Traditional | PDF ↗ |
| K854334 | PAINBLOCKER WA5000 | Wallach Surgical Devices, Inc. | 1986-04-30 | Traditional | PDF ↗ |
| K831963 | CRYOMEDICS NEUROSTAT | Spembly Medical , Ltd. | 1983-08-12 | Traditional | PDF ↗ |
| K781302 | NEUROSTAT, LLOYD | Spembly Medical , Ltd. | 1978-08-15 | Traditional | PDF ↗ |
Product code GXH · Class II · Neurology. Data: openFDA.