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

    NANMA VACUUM PUMP PROXZEK MODEL 2M9498S

    K Number: K041573 · Decision Aug 25, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    86
    Applicant Total
    9
    Review Days
    72

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    NANMA VACUUM PUMP PROXZEK MODEL 2M9498S
    K Number
    K041573
    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
    June 14, 2004
    Decision Date
    August 25, 2004
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LKY), ordered by most recent decision date.

    VACURECT VACUUM CONSTRICTION DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NANMA ADJUSTABLE CONSTRICTION RING

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NANMA VACUUM PUMP

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MODIFICATION TO NANMA VACUUM PUMP

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NANMA ADJUSTABLE CONSTRICTION RING

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VACURECT VACUUM CONSTRICTION DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Nanma Mfg Co., Ltd.

    K Number Device Name
    K030119 NANMA ADJUSTABLE CONSTRICTION RING
    K030913 NANMA VACUUM PUMP
    K013113 MODIFICATION TO NANMA VACUUM PUMP
    K013051 NANMA ADJUSTABLE CONSTRICTION RING
    K013053 MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING
    K993909 NANMA VACUUM PUMP
    K993908 NANMA AJUSTABLE CONSTRICTION RING
    K993906 NANMA NON-ADJUSTABLE CONSTRICTION RING