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

    CERVICAL CATHETER

    K Number: K933981 · Decision Dec 27, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    78
    Same Product Code
    86
    Applicant Total
    9
    Review Days
    498

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    Basic Information

    Device Name
    CERVICAL CATHETER
    K Number
    K933981
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Conceptus, Inc.
    Date Received
    August 16, 1993
    Decision Date
    December 27, 1994
    Product Code
    LKF
    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
    LKF Cannula, Manipulator/Injector, Uterine

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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
    K954164 HYSTEROSCOPE
    K953314 CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM
    K932387 CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDREL
    K932993 INTRAUTERINE CATHETER AND INTRODUCER
    K933723 CONCEPTUS UTERINE CATHETER