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

    SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107

    K Number: K042527 · Decision Nov 8, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    72
    Applicant Total
    8
    Review Days
    52

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    Basic Information

    Device Name
    SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
    K Number
    K042527
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Action Industries, Inc.
    Date Received
    September 17, 2004
    Decision Date
    November 8, 2004
    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 Medical Action Industries, Inc.

    K Number Device Name
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    K022948 VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L
    K946019 SURGICLA INSTRUMENT KIT
    K923846 BURN DRESSING
    K884826 GAUZE SPONGE
    K810685 SUTURE REMOVAL KIT
    K810184 LAPAROTOMY SPONGE