Atlas FDA

GXH

23 FDA 510(k) clearances · Product code

60 daysmedian time to decision
184 days90th percentile
23clearances measured

FDA profile

Official device name
Device, Surgical, Cryogenic
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4250
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
1997: 1 · 2000: 1 · 2018: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
cryoICE cryoXT cryoablation probe (cryoXT) (K250371)AtriCure, Inc.2025-04-10
iovera° System (K243677)Pacira Biosciences, Inc.2024-12-26
AtriCure cryoICE BOX (ACM) (K243157)AtriCure, Inc.2024-10-29
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) (K233170)AtriCure, Inc.2023-10-26
iovera System (K220656)Pacira Biosciences, Inc.2022-05-20
Iovera System (K211334)Pacira Pharmaceuticals, Inc.2021-09-10
AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) (K200697)AtriCure, Inc.2020-12-23
AtriCure cryoICE cryoSPHERE cryoablation probe (K182565)AtriCure, Inc.2018-11-09
iovera system (K173763)Myoscience, Inc.2018-02-28
AtriCure cryoICE cryo-ablation probe (CRYO2) (K180138)AtriCure, Inc.2018-02-15
iovera system (K161835)Myoscience, Inc.2017-03-24
Myoscience iovera system (K142866)Myoscience, Inc.2015-01-21
Atricure Cryo Module System; cryoICE cryoablation probe (K142203)AtriCure, Inc.2014-11-25
IOVERA (K133453)Myoscience, Inc.2014-03-24
CRYO-TOUCH IV (K123516)Myoscience, Inc.2013-01-10
CRYO-TOUCH III (K120415)Myoscience, Inc.2012-06-22
CRYO-TOUCH II (K102021)Myoscience, Inc.2010-09-17
MYOSCIENCE CRYO-TOUCH (K100447)Myoscience, Inc.2010-06-25
CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS (K050272)Cryomedical Instruments, Ltd.2005-03-24
CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE (K031482)Cryomedical Instruemts , Ltd.2003-07-10
PAINBLOCKER WA5000 (K854334)Wallach Surgical Devices, Inc.1986-04-30
CRYOMEDICS NEUROSTAT (K831963)Spembly Medical , Ltd.1983-08-12
NEUROSTAT, LLOYD (K781302)Spembly Medical , Ltd.1978-08-15

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Every clearance here is in the API, with alerts when new ones post.