FDA.reportPublic FDA data

510(k) K233170

Device
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)
Applicant
AtriCure, Inc.
510(k) number
K233170
Product code
GXH
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-26
Date received
2023-09-27
Regulation
882.4250
Classification name
Device, Surgical, Cryogenic
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Erica Schwab
Address
7555 Innovation Way Mason OH US 45040 45040

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GXH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250371cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc.2025-04-10
K243677iovera° SystemPacira Biosciences, Inc.2024-12-26
K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.2024-10-29
K220656iovera SystemPacira Biosciences, Inc.2022-05-20
K211334Iovera SystemPacira Pharmaceuticals, Inc.2021-09-10
K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)AtriCure, Inc.2020-12-23
K182565AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc.2018-11-09
K173763iovera systemMyoscience, Inc.2018-02-28
K180138AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc.2018-02-15
K161835iovera systemMyoscience, Inc.2017-03-24
K142866Myoscience iovera systemMyoscience, Inc.2015-01-21
K142203Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc.2014-11-25
K133453IOVERAMyoscience, Inc.2014-03-24
K123516CRYO-TOUCH IVMyoscience, Inc.2013-01-10
K120415CRYO-TOUCH IIIMyoscience, Inc.2012-06-22