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

    CANNULA, PERFUSION, FALLOPIAN TUBE

    K Number: K772230 · Decision Jan 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    78
    Same Product Code
    86
    Applicant Total
    18
    Review Days
    28

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    Basic Information

    Device Name
    CANNULA, PERFUSION, FALLOPIAN TUBE
    K Number
    K772230
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    J. Sklar Mfg. Co., Inc.
    Date Received
    December 6, 1977
    Decision Date
    January 3, 1978
    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 J. Sklar Mfg. Co., Inc.

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    K842111 KOGAN ENDOSPECULUM 9-1/2
    K822448 SCISSORS, VARIOUS
    K802457 KEVORKIAN-YOUNGE BIOPSY PUNCH, #90-6610
    K802458 KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611
    K801273 MAGILL CATHETER INTRO. FORCEPS
    K800441 RUDD-CLINIC HEMORRHOIDAL FORCEPS
    K790577 HEMORRHOIDAL LIGATOR
    K772229 MINICLAMPS, STABILIZ., FALLOPIAN TUBE
    Search all 18 clearances from J. Sklar Mfg. Co., Inc. →