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

    I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000

    K Number: K052175 · Decision Oct 17, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    64
    Applicant Total
    8
    Review Days
    68

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    Basic Information

    Device Name
    I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000
    K Number
    K052175
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Uroplasty, Inc.
    Date Received
    August 10, 2005
    Decision Date
    October 17, 2005
    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 Uroplasty, Inc.

    K Number Device Name
    K121337 UROPLASTY RIGID ENDOSCPIC NEEDLES
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    K091391 UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518
    K071822 URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12
    K061333 URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12
    K052025 URGENT PC NEUROMODULATION SYSTEM
    K051905 UROPLASTY RIGID ENDOSCOPIC NEEDLE