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

    CUSTOMED CYSTO PACK I

    K Number: K902274 · Decision Sep 20, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    91
    Applicant Total
    36
    Review Days
    122

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    Basic Information

    Device Name
    CUSTOMED CYSTO PACK I
    K Number
    K902274
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Customed, Inc.
    Date Received
    May 21, 1990
    Decision Date
    September 20, 1990
    Product Code
    FAJ
    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
    FAJ Cystoscope And Accessories, Flexible/Rigid

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    Other Clearances by Customed, Inc.

    K Number Device Name
    K974647 FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633
    K971920 GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)
    K964011 SUCTION CATHETER TRAY PRODUCT NO. 900277
    K962652 URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
    K962596 CUSTOMED BLOOD EXTRACTION KIT
    K961442 UNIVERSAL DRAINAGE TRAY
    K953678 STERIMED STERIZATION WRAPPER (NON-STERILE)
    K950295 WOUND CLOSURE/LACERATION TRAY
    K942177 FOLEY CATHETERIZATION TRAY
    K925018 IV PREP KIT W/O DRESSING (NON-STERILE)
    Search all 36 clearances from Customed, Inc. →