Atlas FDA

iovera° System

FDA 510(k) clearance K243677 · decided 2024-12-26

Clearance details

K-number
K243677
Device name
iovera° System
Applicant
Pacira Biosciences, Inc.
Decision
Substantially Equivalent
Date received
2024-11-27
Decision date
2024-12-26
Days to decision
29 days
Clearance type
Special
Product code
GXH
Device class
2
Regulation number
882.4250
Medical specialty
Neurology
Advisory committee
Neurology
Location
San Diego, CA, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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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

Recalls involving this device

No recalls on record reference this clearance.