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510(k) Data Aggregation

    K Number
    K982042
    Device Name
    ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002
    Manufacturer
    ISLAND BIOSURGICAL, INC.
    Date Cleared
    1998-09-08

    (90 days)

    Product Code
    OTN
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Island Biosurgical, Inc. Bladder Neck Suspension Bolster is to be used by operating pelvic surgeons to surgically correct female stress urinary incontinence due to pelvic relaxation. This bolster is recommended where the possibility of reduced suture and mosh reaction is desired.

    Device Description

    A surgically implantable polypropylene mesh bolster with monofilament sutures.

    AI/ML Overview

    The provided text is a 510(k) summary for the Island Biosurgical Bladder Neck Suspension Bolster. It explicitly states:

    "Performance testing: Performance testing was not included in this 510 (k)."

    Therefore, based on the provided document, there is no information available regarding acceptance criteria, device performance against such criteria, or any study that proves the device meets acceptance criteria.

    As a result, I cannot provide the requested information. This device received substantial equivalence without requiring performance testing to demonstrate its safety and effectiveness.

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