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510(k) Data Aggregation

    K Number
    K243897

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-11-12

    (328 days)

    Product Code
    Regulation Number
    878.4840
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    PDS™ Plus Suture is indicated for use in general soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur. PDS™ Plus Suture is not indicated in adult cardiovascular and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.

    Device Description

    PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture is a sterile synthetic absorbable monofilament suture made from the polyester poly (p-dioxanone). The empirical molecular formula of the polymer is (C₄H₆O₃)ₙ.

    PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture is available undyed and dyed with D&C Violet No. 2.

    PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture contains Triclosan, a broad spectrum antibacterial agent, ranging between 42 – 2360 µg of Triclosan per meter of suture. The maximum of 2360 µg/m falls well below literature values for toxicity of Triclosan based on a single worst-case dose.

    The lower specification limit is set at a value where claims for in-vitro antibacterial activity can be supported across all product variants throughout their shelf-life.

    AI/ML Overview

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