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

    Exablate Prostate System

    K Number: K212150 · Decision Nov 23, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    137

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    Basic Information

    Device Name
    Exablate Prostate System
    K Number
    K212150
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4340
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Insightec, Inc.
    Date Received
    July 9, 2021
    Decision Date
    November 23, 2021
    Product Code
    PLP
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PLP High Intensity Ultrasound System For Prostate Tissue Ablation

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