BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    HTx Disposable Hysteroscope System

    K Number: K231260 · Decision Mar 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    170
    Applicant Total
    2
    Review Days
    309

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    HTx Disposable Hysteroscope System
    K Number
    K231260
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suzhou AcuVu Medical Technology Co., Ltd.
    Date Received
    May 1, 2023
    Decision Date
    March 5, 2024
    Product Code
    HIH
    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
    HIH Hysteroscope (And Accessories)

    Similar 510(k) Clearances

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

    Strauss Surgical Resection Instruments

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

    Manual Tissue Removal Device

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

    InnovexView (GC146-17, GC150-20, GC155-23)

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

    ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)

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

    SPY Cystoscope/Hysteroscope

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

    RZ Resectoscope System

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

    Other Clearances by Suzhou AcuVu Medical Technology Co., Ltd.

    K Number Device Name
    K254050 Manual Tissue Removal Device