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510(k) Data Aggregation

    K Number
    K070065
    Device Name
    AMS SINGLE INCISION SLING SYSTEM (SIS-0)
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Date Cleared
    2007-03-01

    (52 days)

    Product Code
    PAH
    Regulation Number
    878.3300
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K023516
    Why did this record match?
    Device Name :

    AMS SINGLE INCISION SLING SYSTEM (SIS-0)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Single Incision Sling System is intended for the placement of a suburethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

    Device Description

    The AMS Single Incision Sling System is a modification of Monarc consisting of a sling and a surgical instrument (called a "Needle Passer" or Surgical Needle Instrument") for sub-urethral sling placement. The slings are made from polymeric mesh.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance metrics, or details of a study with sample sizes, expert involvement, or ground truth establishment.

    The document is a 510(k) summary statement for the AMS Single Incision Sling System, primarily discussing its device description, indications for use, and its substantial equivalence to a predicate device. It also includes an FDA letter confirming the 510(k) clearance.

    Therefore, I cannot fulfill your request for the tables and study details based on the provided input.

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