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

    COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER

    K Number: K023383 · Decision Dec 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    52
    Applicant Total
    6
    Review Days
    66

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    Basic Information

    Device Name
    COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER
    K Number
    K023383
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6110
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cooper Surgical
    Date Received
    October 8, 2002
    Decision Date
    December 13, 2002
    Product Code
    MQF
    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
    MQF Catheter, Assisted Reproduction

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    Other Clearances by Cooper Surgical

    K Number Device Name
    K253698 Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes
    K091325 TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS
    K023382 COOPERSURGICAL MALLEABLE SYTLET
    K023384 COOPERSURGICAL TRIAL TRANSFER CATHETER
    K023379 COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER