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

    CYSTOSCOPY/IRRIGATION SET

    K Number: K896211 · Decision Jan 18, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    28
    Review Days
    84

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    Basic Information

    Device Name
    CYSTOSCOPY/IRRIGATION SET
    K Number
    K896211
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Westmark, Sterile Packing Systems, Inc. (Sps)
    Date Received
    October 26, 1989
    Decision Date
    January 18, 1990
    Product Code
    KOD
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KOD Catheter, Urological

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    Other Clearances by Westmark, Sterile Packing Systems, Inc. (Sps)

    K Number Device Name
    K896800 IRRIGATION TRAY
    K896799 PARACERVICAL/PUDENDAL TRAYS
    K896559 INFANT FEEDING TUBE
    K896794 SPECIMEN CONTAINER
    K896806 CATHETER PLUG/PROTECTOR
    K896798 TRACHEOSTOMY TRAY
    K896797 SUCTION CATHETER KIT
    K896215 MERCY HIP/KNEE PACK
    K896804 MANIFOLD
    K896556 UNIVERSAL POOLE SUCTION TUBE
    Search all 28 clearances from Westmark, Sterile Packing Systems, Inc. (Sps) →