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

    RF Vapor System

    K Number: K213627 · Decision Dec 17, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    5
    Review Days
    30

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    Basic Information

    Device Name
    RF Vapor System
    K Number
    K213627
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aqua Medical, Inc.
    Date Received
    November 17, 2021
    Decision Date
    December 17, 2021
    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
    K211282 Aqua Medical RF Vapor System
    K183595 Aqua Medical RF Vapor System