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

    OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES

    K Number: K945265 · Decision Sep 12, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    170
    Applicant Total
    10
    Review Days
    319

    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
    OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES
    K Number
    K945265
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Optus, Inc.
    Date Received
    October 28, 1994
    Decision Date
    September 12, 1995
    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 Optus, Inc.

    K Number Device Name
    K945264 OPTUS OTOSCOPES
    K953913 OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES
    K945268 OPTUS BRONCHOSCOPES
    K945262 OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES
    K945267 OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES
    K945266 OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES
    K944656 OPTUS SINUSCOPES AND ACCESSORIES
    K945263 OPTUS THORACOSCOPES
    K945269 OPTUS LARYNGOSCOPES