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510(k) Data Aggregation

    K Number
    K040042
    Device Name
    MEDISIL SILICONE SHEETING
    Manufacturer
    MEDISIL CORPORATION
    Date Cleared
    2004-04-01

    (80 days)

    Product Code
    MIB
    Regulation Number
    874.3620
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDISIL CORPORATION

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

    Sheeting is indicated for short term use for nasal splinting, wound dressings, scar coverings and temporary joint spacers.

    For long term use, this device is indicated for tympanic membrane repair, dural covering, nasal septal repair, tendon anastamosis and neural repair, correction of strabismus, galea repair, orbital floor repair, hemodialysis shunt anchors, facilitation of osteogenesis, repair of urethral strictures, staged repair of omphalocoel and repair of orbital floor fractures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device named "Medisil Silicone Sheeting," indicating that the device has been found substantially equivalent to a legally marketed predicate device.

    The letter lists the indications for use but does not contain any details about performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information in the suggested format.

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