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

    URETERAL STENT

    K Number: K871667 · Decision Jun 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    8
    Review Days
    43

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    Basic Information

    Device Name
    URETERAL STENT
    K Number
    K871667
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Penn Medical Devices, Inc.
    Date Received
    April 28, 1987
    Decision Date
    June 10, 1987
    Product Code
    FAD
    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
    FAD Stent, Ureteral

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    Other Clearances by Penn Medical Devices, Inc.

    K Number Device Name
    K873949 RORERTAZZI NASOPHARYNGEAL AIRWAY
    K873176 HUFFMAN BIOPSY UNIT
    K873177 DEVINE (SUPRAPUBIC SOUND AND GUIDE)
    K873178 URETERAL BULB DILATORS
    K870508 GASTROINTESTINAL TUBE
    K862729 PENN 3-RING HANDLE
    K862107 PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR