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

    SHEATHES STERILE ULTRASOUND GEL

    K Number: K130041 · Decision Feb 6, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    33
    Applicant Total
    7
    Review Days
    29

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    Basic Information

    Device Name
    SHEATHES STERILE ULTRASOUND GEL
    K Number
    K130041
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sheathing Technologies, Inc.
    Date Received
    January 8, 2013
    Decision Date
    February 6, 2013
    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

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    Other Clearances by Sheathing Technologies, Inc.

    K Number Device Name
    K153212 Sheathes Ultrasound Probe Covers
    K112827 SHEATHES ULTRASOND GEL
    K100966 COLONOSCOPE/SIGMOIDOSCOPE SHEATHES
    K091828 SHEATHESISO ULTRASOUND TRANSDUCER COVER
    K043425 SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)
    K990175 SHEATHES (NON-LATEX), STERILE