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

    MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING

    K Number: K013053 · Decision May 9, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    86
    Applicant Total
    9
    Review Days
    240

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    Basic Information

    Device Name
    MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING
    K Number
    K013053
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5020
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nanma Mfg Co., Ltd.
    Date Received
    September 11, 2001
    Decision Date
    May 9, 2002
    Product Code
    LKY
    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
    LKY Device, External Penile Rigidity

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    Other Clearances by Nanma Mfg Co., Ltd.

    K Number Device Name
    K041573 NANMA VACUUM PUMP PROXZEK MODEL 2M9498S
    K030119 NANMA ADJUSTABLE CONSTRICTION RING
    K030913 NANMA VACUUM PUMP
    K013113 MODIFICATION TO NANMA VACUUM PUMP
    K013051 NANMA ADJUSTABLE CONSTRICTION RING
    K993909 NANMA VACUUM PUMP
    K993908 NANMA AJUSTABLE CONSTRICTION RING
    K993906 NANMA NON-ADJUSTABLE CONSTRICTION RING