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

    Ultra/Phonic Conductivity Gel

    K Number: K163024 · Decision Jan 8, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    33
    Applicant Total
    5
    Review Days
    434

    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
    Ultra/Phonic Conductivity Gel
    K Number
    K163024
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pharmaceutical Innovations, Inc.
    Date Received
    October 31, 2016
    Decision Date
    January 8, 2018
    Product Code
    MUI
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MUI Media, Coupling, Ultrasound

    Similar 510(k) Clearances

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

    Non-Sterile Ultrasound Gel Sterile Ultrasound Gel

    FDA 510(k)
    FDA Class 2 ·Radiology

    EdgeFlow Gel Pad

    FDA 510(k)
    FDA Class 2 ·Radiology

    Sterile and Non-Sterile Ultrasonic Coupling Agent

    FDA 510(k)
    FDA Class 2 ·Radiology

    Non-Sterile Ultrasound Transmission Gels

    FDA 510(k)
    FDA Class 2 ·Radiology

    Sterile and Non-Sterile Ultrasound Gels

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ultrasound Transmission Gels

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

    Other Clearances by Pharmaceutical Innovations, Inc.

    K Number Device Name
    K163027 Ultra/Phonic Free Conductivity Gel
    K163026 Ultra/Phonic Scanning Gel
    K163023 Other-Sonic Transmission Gel
    K961222 EVRON GEL