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

    PENN 3-RING HANDLE

    K Number: K862729 · Decision Oct 24, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    51
    Applicant Total
    8
    Review Days
    98

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    Basic Information

    Device Name
    PENN 3-RING HANDLE
    K Number
    K862729
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4680
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Penn Medical Devices, Inc.
    Date Received
    July 18, 1986
    Decision Date
    October 24, 1986
    Product Code
    FFL
    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
    FFL Dislodger, Stone, Basket, Ureteral, Metal

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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
    K871667 URETERAL STENT
    K870508 GASTROINTESTINAL TUBE
    K862107 PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR