FDA 510(k) Applications for Medical Device Product Code "GXH"
(Device, Surgical, Cryogenic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K200697 | AtriCure Inc. | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) | 12/23/2020 |
| K142203 | ATRICURE, INC. | Atricure Cryo Module System; cryoICE cryoablation probe | 11/25/2014 |
| K243157 | AtriCure, Inc. | AtriCure cryoICE BOX (ACM) | 10/29/2024 |
| K180138 | AtriCure, Inc. | AtriCure cryoICE cryo-ablation probe (CRYO2) | 02/15/2018 |
| K182565 | AtriCure, Inc. | AtriCure cryoICE cryoSPHERE cryoablation probe | 11/09/2018 |
| K233170 | AtriCure, Inc. | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) | 10/26/2023 |
| K250371 | AtriCure, Inc. | cryoICE cryoXT cryoablation probe (cryoXT) | 04/10/2025 |
| K031482 | CRYOMEDICAL INSTRUEMTS LTD. | CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE | 07/10/2003 |
| K050272 | CRYOMEDICAL INSTRUMENTS, LTD. | CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS | 03/24/2005 |
| K102021 | MYOSCIENCE INC | CRYO-TOUCH II | 09/17/2010 |
| K120415 | MYOSCIENCE INC | CRYO-TOUCH III | 06/22/2012 |
| K123516 | MYOSCIENCE INC | CRYO-TOUCH IV | 01/10/2013 |
| K133453 | MYOSCIENCE INC | IOVERA | 03/24/2014 |
| K100447 | MYOSCIENCE INC | MYOSCIENCE CRYO-TOUCH | 06/25/2010 |
| K161835 | Myoscience, Inc | iovera system | 03/24/2017 |
| K173763 | Myoscience, Inc | iovera system | 02/28/2018 |
| K142866 | Myoscience, Inc | Myoscience iovera system | 01/21/2015 |
| K220656 | Pacira Biosciences, Inc. | iovera System | 05/20/2022 |
| K243677 | Pacira Biosciences, Inc. | iovera░ System | 12/26/2024 |
| K211334 | Pacira Pharmaceuticals Inc. | Iovera System | 09/10/2021 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
