BEUDAMED
    Product Code: PWJ FDA class 2 21 CFR 884.4910

    Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence

    Obstetrics/Gynecology

    The Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence is an obstetrics/gynecology device consisting of instruments used to aid in the insertion, placement, fixation, or anchoring of surgical mesh slings for the treatment of stress urinary incontinence, a condition characterized by involuntary urine leakage during physical exertion, coughing, or sneezing. It is classified as FDA Class II under regulation 21 CFR 884.4910, requiring 510(k) premarket notification clearance and compliance with general and special controls. The product code is PWJ, reviewed under the Gastroenterology/Urology panel. It is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    5
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    5
    Years Active
    1

    Basic Information

    Product Code
    PWJ
    Device Class
    FDA class 2
    Regulation Number
    884.4910
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 5 510(k) clearances via K numbers.

    K Number Device Name
    K181151 GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System
    K173019 GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar
    K173162 GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide
    K172614 Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left
    K172565 Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device

    FEI Numbers

    This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.