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

    ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM

    K Number: K950255 · Decision Aug 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    170
    Applicant Total
    6
    Review Days
    213

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    Basic Information

    Device Name
    ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM
    K Number
    K950255
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Argus Medical Co., Inc.
    Date Received
    January 23, 1995
    Decision Date
    August 24, 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)

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    Other Clearances by Argus Medical Co., Inc.

    K Number Device Name
    K951624 ARGUS MEDICAL COMPANY LAPAROSCOPIC DISCECTOMY INSTRUMENT SYSTEM
    K950242 ARGUS ARTHROSCOPY INSTRUMENT SYSTEM
    K950297 ARGUS ENDOSCOPIC PLASTIC SURGERY INSTRUMENT SYSTEM
    K946011 ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM
    K950378 ARGUS LAPAROSCOPY INSTRUMENT SYSTEM