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

    ABDOMINAL PRESSURE CONTROL VALVE

    K Number: K844829 · Decision May 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    47
    Applicant Total
    14
    Review Days
    140

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    Basic Information

    Device Name
    ABDOMINAL PRESSURE CONTROL VALVE
    K Number
    K844829
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4550
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    L.A.S.E.R., Inc.
    Date Received
    December 12, 1984
    Decision Date
    May 1, 1985
    Product Code
    HHR
    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
    HHR Laser, Surgical, Gynecologic

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    K931561 TROCAR SLEEVE
    K933421 ENDOSCOPIC INSTRUMENTS AND ACCESSDORIES
    K924844 BULK TISSUE REMOVAL SYSTEM
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    K931092 ENDOSCOPIC RETRACTOR
    K914197 ALLOY SCALPEL HANDPIECES
    K904638 TROCAR DISPOSABLE
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