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

    GASTROINTESTINAL TUBE

    K Number: K870508 · Decision May 11, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    8
    Review Days
    95

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    Basic Information

    Device Name
    GASTROINTESTINAL TUBE
    K Number
    K870508
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Penn Medical Devices, Inc.
    Date Received
    February 5, 1987
    Decision Date
    May 11, 1987
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by Penn Medical Devices, Inc.

    K Number Device Name
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    K873177 DEVINE (SUPRAPUBIC SOUND AND GUIDE)
    K873178 URETERAL BULB DILATORS
    K871667 URETERAL STENT
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    K862107 PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR