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

    Acessa ProVu System

    K Number: K181124 · Decision Sep 28, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    151

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    Basic Information

    Device Name
    Acessa ProVu System
    K Number
    K181124
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acessa Health, Inc.
    Date Received
    April 30, 2018
    Decision Date
    September 28, 2018
    Product Code
    HFG
    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
    HFG Coagulator, Laparoscopic, Unipolar (And Accessories)

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