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510(k) K211334

Iovera System by Pacira Pharmaceuticals, Inc. — Product Code GXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2021
Date Received
May 3, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Surgical, Cryogenic
Device Class
Class II
Regulation Number
882.4250
Review Panel
NE
Submission Type

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  • K182565 — AtriCure cryoICE cryoSPHERE cryoablation probe (November 9, 2018)
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  • K180138 — AtriCure cryoICE cryo-ablation probe (CRYO2) (February 15, 2018)
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