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

    RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)

    K Number: K991895 · Decision Aug 12, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    41
    Applicant Total
    4
    Review Days
    70

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    Basic Information

    Device Name
    RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)
    K Number
    K991895
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1175
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ri Mos. S.R.L.
    Date Received
    June 3, 1999
    Decision Date
    August 12, 1999
    Product Code
    HHK
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HHK Curette, Suction, Endometrial (And Accessories)

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    Other Clearances by Ri Mos. S.R.L.

    K Number Device Name
    K992926 GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195)
    K991827 GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043
    K983897 CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G