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

    AMSINO CERVICAL SCRAPER

    K Number: K950780 · Decision Jul 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    72
    Applicant Total
    9
    Review Days
    154

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    Basic Information

    Device Name
    AMSINO CERVICAL SCRAPER
    K Number
    K950780
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Amsino Intl., Inc.
    Date Received
    February 21, 1995
    Decision Date
    July 25, 1995
    Product Code
    HHT
    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
    HHT Spatula, Cervical, Cytological

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    Other Clearances by Amsino Intl., Inc.

    K Number Device Name
    K070873 AMSURE BLADDER IRRIGATION SET
    K992719 AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE
    K974042 AMSURE CLEANSING ENEMA SET
    K973107 AMSINO I.V. ADMINISTRATION SET
    K973199 AMSINO SUCTION CATHETER
    K971929 AMSINO URINARY LEG BAG
    K964745 AMSINO URINARY DRAINAGE BAG
    K951528 AMSINO DISPOSABLE VIGINAL SPECULUM