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

    Symphion Operative Hysteroscopy System

    K Number: K233710 · Decision Jan 17, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    58

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    Basic Information

    Device Name
    Symphion Operative Hysteroscopy System
    K Number
    K233710
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1710
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Minerva Surgical, Inc.
    Date Received
    November 20, 2023
    Decision Date
    January 17, 2024
    Product Code
    PGT
    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
    PGT Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar

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