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 |
K180138 |
AtriCure, Inc. |
AtriCure cryoICE cryo-ablation probe (CRYO2) |
02/15/2018 |
K182565 |
AtriCure, Inc. |
AtriCure cryoICE cryoSPHERE cryoablation probe |
11/09/2018 |
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 |
K211334 |
Pacira Pharmaceuticals Inc. |
Iovera System |
09/10/2021 |
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