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

    Aqua Medical RF Vapor System

    K Number: K183595 · Decision Jun 21, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    5
    Review Days
    182

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    Basic Information

    Device Name
    Aqua Medical RF Vapor System
    K Number
    K183595
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aqua Medical, Inc.
    Date Received
    December 21, 2018
    Decision Date
    June 21, 2019
    Product Code
    KNS
    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
    KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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    Other Clearances by Aqua Medical, Inc.

    K Number Device Name
    K251226 Aqua Medical RF Vapor Ablation System
    K241271 Aqua Medical RF Vapor Ablation System
    K213627 RF Vapor System
    K211282 Aqua Medical RF Vapor System