Product code GXH
- Device name
- Device, Surgical, Cryogenic
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4250
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250371 | cryoICE cryoXT cryoablation probe (cryoXT) | AtriCure, Inc. | 2025-04-10 |
| K243677 | iovera° System | Pacira Biosciences, Inc. | 2024-12-26 |
| K243157 | AtriCure cryoICE BOX (ACM) | AtriCure, Inc. | 2024-10-29 |
| 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 |
| K220656 | iovera System | Pacira Biosciences, Inc. | 2022-05-20 |
| K211334 | Iovera System | Pacira Pharmaceuticals, Inc. | 2021-09-10 |
| K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) | AtriCure, Inc. | 2020-12-23 |
| K182565 | AtriCure cryoICE cryoSPHERE cryoablation probe | AtriCure, Inc. | 2018-11-09 |
| K173763 | iovera system | Myoscience, Inc. | 2018-02-28 |
| K180138 | AtriCure cryoICE cryo-ablation probe (CRYO2) | AtriCure, Inc. | 2018-02-15 |
| K161835 | iovera system | Myoscience, Inc. | 2017-03-24 |
| K142866 | Myoscience iovera system | Myoscience, Inc. | 2015-01-21 |
| K142203 | Atricure Cryo Module System; cryoICE cryoablation probe | AtriCure, Inc. | 2014-11-25 |
| K133453 | IOVERA | Myoscience, Inc. | 2014-03-24 |
| K123516 | CRYO-TOUCH IV | Myoscience, Inc. | 2013-01-10 |
| K120415 | CRYO-TOUCH III | Myoscience, Inc. | 2012-06-22 |
| K102021 | CRYO-TOUCH II | Myoscience, Inc. | 2010-09-17 |
| K100447 | MYOSCIENCE CRYO-TOUCH | Myoscience, Inc. | 2010-06-25 |
| K050272 | CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS | Cryomedical Instruments, Ltd. | 2005-03-24 |
| K031482 | CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE | Cryomedical Instruemts , Ltd. | 2003-07-10 |
| K854334 | PAINBLOCKER WA5000 | Wallach Surgical Devices, Inc. | 1986-04-30 |
| K831963 | CRYOMEDICS NEUROSTAT | Spembly Medical , Ltd. | 1983-08-12 |
| K781302 | NEUROSTAT, LLOYD | Spembly Medical , Ltd. | 1978-08-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00818788022295 | Epimed International, Inc. | EPIMED INTERNATIONAL, INC | 2025-12-05 |
| 10840143917004 | AtriCure cryoICE cryoXT | ATRICURE, INC. | 2025-10-01 |
| 10840143912863 | AtriCure cryoICE cryoXT | ATRICURE, INC. | 2025-04-25 |
| 30840143912867 | AtriCure cryoICE cryoXT | ATRICURE, INC. | 2025-04-25 |
| 10840143911750 | AtriCure cryoICE cryoSPHERE MAX Cryoablation System | ATRICURE, INC. | 2024-02-15 |
| 10840143911743 | AtriCure cryoICE cryoSPHERE MAX Cryoablation System | ATRICURE, INC. | 2024-02-15 |
| 10840143911736 | AtriCure cryoICE cryoSPHERE+ Cryoablation System | ATRICURE, INC. | 2024-02-15 |
| 10840143911729 | AtriCure cryoICE cryoSPHERE+ Cryoablation System | ATRICURE, INC. | 2024-02-15 |
| 00816287020217 | iovera Smart Tip | Pacira Pharmaceuticals, Inc. | 2023-06-15 |
| 00816287020132 | iovera Smart Tip | PACIRA CRYOTECH, INC. | 2023-06-15 |
| 00816287020231 | iovera Smart Tip | Pacira Pharmaceuticals, Inc. | 2023-06-15 |
| 00816287020187 | iovera Smart Tip | Pacira Pharmaceuticals, Inc. | 2023-06-15 |
| 00816287020149 | iovera Smart Tip | Pacira Pharmaceuticals, Inc. | 2023-06-15 |
| 00816287020170 | iovera Smart Tip | PACIRA CRYOTECH, INC. | 2023-06-15 |
| 00816287020200 | iovera Smart Tip | PACIRA CRYOTECH, INC. | 2023-06-15 |
| 00816287020224 | iovera Smart Tip | PACIRA CRYOTECH, INC. | 2023-06-15 |
| 00816287020248 | iovera | Pacira Pharmaceuticals, Inc. | 2023-06-13 |
| 30840143902646 | AtriCure cryoICE Cryoablation System (CRYO2) | ATRICURE, INC. | 2021-01-08 |
| 30840143902912 | AtriCure cryoICE cryoSPHERE Cryoablation System | ATRICURE, INC. | 2021-01-08 |
| 30840143902929 | AtriCure cryoICE cryoSPHERE Cryoablation System | ATRICURE, INC. | 2021-01-08 |
| 10840143902321 | AtriCure cryoICE Cryoablation System (CRYO2) | ATRICURE, INC. | 2021-01-08 |
| 30840143902608 | cryoICE Cryoablation System | ATRICURE, INC. | 2021-01-08 |
| 10840143902550 | AtriCure cryoICE cryoSPHERE Cryoablation System | ATRICURE, INC. | 2021-01-08 |
| 10840143902543 | AtriCure cryoICE cryoSPHERE Cryoablation System | ATRICURE, INC. | 2021-01-08 |
| 10840143902307 | cryoICE Cryoablation System | ATRICURE, INC. | 2021-01-08 |
| 00818354017885 | AtriCure cryoICE Cryoablation System (CRYO2) | ATRICURE, INC. | 2020-03-18 |
| 00816287020071 | iovera | Pacira Pharmaceuticals, Inc. | 2020-02-12 |
| 00818354016321 | AtriCure cryoICE cryoSPHERE Cryoablation System | ATRICURE, INC. | 2018-11-15 |
| 00818354016123 | cryoICE Cryoablation System | ATRICURE, INC. | 2018-04-01 |
| 00818354011340 | cryoICE Cryoablation System | ATRICURE, INC. | 2016-10-24 |