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

    BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996

    K Number: K040538 · Decision Mar 17, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    64
    Applicant Total
    72
    Review Days
    15

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    Basic Information

    Device Name
    BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996
    K Number
    K040538
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Medical Systems, Inc.
    Date Received
    March 2, 2004
    Decision Date
    March 17, 2004
    Product Code
    OTN
    Advisory Committee
    General, Plastic Surgery
    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
    OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

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    Other Clearances by American Medical Systems, Inc.

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    K090934 PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
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    K090713 ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP
    K082677 AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
    K082730 AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE
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