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510(k) Data Aggregation

    K Number
    K030926
    Device Name
    FAST THROW STAINLESS STEEL SURGICAL SUTURE
    Manufacturer
    ADVANCED SURGICAL PRODUCTS, INC.
    Date Cleared
    2003-07-21

    (119 days)

    Product Code
    FZP,GAQ
    Regulation Number
    878.4300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K933686,K931271,K931915,K970793
    Why did this record match?
    Device Name :

    FAST THROW STAINLESS STEEL SURGICAL SUTURE

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

    The "Fast Throw" Stainless Steel Surgical Suture is indicated for use in superficial skin closure.

    Device Description

    The Advanced Surgical Products "Fast Throw" Stainless Steel Surgical Suture is a sterile single use knot-less suture that is primarily designed for skin wound closure The device incorporates barbs along the length of the suture and works in conjunction with a Tshaped backstop incorporated at the proximal end of the device. As the suture is passed through the wound, the wound is cinched up to the T-shaped backstop.

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device (a surgical suture), not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment is not applicable in the context of AI/ML performance evaluation.

    The document describes the device, its intended use, comparison to predicate devices, and pre-clinical data (needle attachment pull strength and tensile testing per USP standards, and in vivo testing). The FDA determined substantial equivalence based on this information.

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