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

    LAPAROTOMY BLADDER NECK SUSPENSION KIT

    K Number: K971801 · Decision Jul 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    12
    Review Days
    68

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    Basic Information

    Device Name
    LAPAROTOMY BLADDER NECK SUSPENSION KIT
    K Number
    K971801
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Louisville Laboratories, Inc.
    Date Received
    May 15, 1997
    Decision Date
    July 22, 1997
    Product Code
    EZL
    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
    EZL Catheter, Retention Type, Balloon

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    Other Clearances by Louisville Laboratories, Inc.

    K Number Device Name
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    K971791 VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION
    K971802 VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION
    K971797 LAPAROSCOPIC BLADDER NECK SUSPENSION KIT
    K963076 LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY
    K960882 CONTROL SYRINGE
    K955535 LOUISVILLE LABS OXYGEN HEAD TENT
    K946282 UNIVERSAL URETHRAL CATHETER
    K932979 EXTERNAL STABILITY PAD
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