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

    Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1

    K Number: K193516 · Decision May 4, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    43
    Applicant Total
    8
    Review Days
    137

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    Basic Information

    Device Name
    Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
    K Number
    K193516
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gynesonics, Inc.
    Date Received
    December 19, 2019
    Decision Date
    May 4, 2020
    Product Code
    KNF
    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
    KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KNF), ordered by most recent decision date.

    Sonata Transcervical Fibroid Ablation System 2.2

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Sonata Transcervical Fibroid Ablation System 2.2

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Sonata Transcervical Fibroid Ablation System 2.2

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Sonata Transcervical Fibroid Ablation System 2.2

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Sonata Sonography-Guided Transcervical Fibroid Ablation System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Gynesonics, Inc.

    K Number Device Name
    K250705 Sonata Transcervical Fibroid Ablation System 2.2
    K240503 Sonata Transcervical Fibroid Ablation System 2.2
    K233848 Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
    K222304 Sonata Transcervical Fibroid Ablation System 2.2
    K211535 Sonata Transcervical Fibroid Ablation System 2.2
    K173703 Sonata Sonography-Guided Transcervical Fibroid Ablation System
    K061153 GYNESONICS EC6 TRANSDUCER