BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    SILCLEAR TUBING (MODIFICATION)

    K Number: K953864 · Decision Nov 6, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    19
    Review Days
    91

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    Basic Information

    Device Name
    SILCLEAR TUBING (MODIFICATION)
    K Number
    K953864
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Degania Silicone , Ltd.
    Date Received
    August 7, 1995
    Decision Date
    November 6, 1995
    Product Code
    FPK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FPK Tubing, Fluid Delivery

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    Other Clearances by Degania Silicone , Ltd.

    K Number Device Name
    K254170 Percutaneous Endoscopic Gastrostomy (PEG) Kit
    K233591 Stylus
    K152246 Aquarius Stoma Measuring Device
    K143378 AQUARIUS Gastrostomy Replacement Tube
    K141753 AQUARIUS NASAL FEEDING TUBE
    K141631 AQUARIUS EXTENSION FEEDING SET
    K132686 AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE
    K131020 TEMPERATURE SENSOR CATHETER
    K122030 LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON
    K103371 COUDE/ OR TIEMANN
    Search all 19 clearances from Degania Silicone , Ltd. →