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510(k) Data Aggregation

    K Number
    K072076
    Device Name
    CYTOPLAST PTFE SUTURE
    Manufacturer
    OSTEOGENICS BIOMEDICAL, INC.
    Date Cleared
    2007-10-31

    (93 days)

    Product Code
    NBY
    Regulation Number
    878.5035
    Type
    Abbreviated
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CYTOPLAST PTFE SUTURE

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

    The Cytoplast® PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental and general surgeries, as well as repair of the dura mater. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "Cytoplast PTFE Suture." It confirms that the device has been found substantially equivalent to a predicate device.

    This document DOES NOT contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

    The document primarily focuses on regulatory clearance, device classification, and indications for use. It does not include performance data, clinical study details, or analytical validation results.

    Therefore, I cannot extract the requested information regarding acceptance criteria and performance study details from the provided text.

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