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

    HYSTEROSCOPE

    K Number: K954164 · Decision Mar 12, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    170
    Applicant Total
    9
    Review Days
    189

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    Basic Information

    Device Name
    HYSTEROSCOPE
    K Number
    K954164
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Conceptus, Inc.
    Date Received
    September 5, 1995
    Decision Date
    March 12, 1996
    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 Conceptus, Inc.

    K Number Device Name
    K974028 STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING
    K972210 RESECTOSCOPE SAFETY SHEATH
    K962587 CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM
    K953314 CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM
    K932387 CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDREL
    K932993 INTRAUTERINE CATHETER AND INTRODUCER
    K933723 CONCEPTUS UTERINE CATHETER
    K933981 CERVICAL CATHETER