BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    iovera° System

    K Number: K243677 · Decision Dec 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    22
    Applicant Total
    2
    Review Days
    29

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    iovera° System
    K Number
    K243677
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4250
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pacira Biosciences, Inc.
    Date Received
    November 27, 2024
    Decision Date
    December 26, 2024
    Product Code
    GXH
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GXH Device, Surgical, Cryogenic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GXH), ordered by most recent decision date.

    cryoICE cryoXT cryoablation probe (cryoXT)

    FDA 510(k)
    FDA Class 2 ·Neurology

    AtriCure cryoICE BOX (ACM)

    FDA 510(k)
    FDA Class 2 ·Neurology

    cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)

    FDA 510(k)
    FDA Class 2 ·Neurology

    iovera System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Iovera System

    FDA 510(k)
    FDA Class 2 ·Neurology

    AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Pacira Biosciences, Inc.

    K Number Device Name
    K220656 iovera System