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510(k) Data Aggregation

    K Number
    K253852

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-02-06

    (66 days)

    Product Code
    Regulation Number
    878.4493
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

    Device Description

    MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture is a sterile synthetic absorbable monofilament suture composed of a copolymer of glycolide and (epsilon) ε-caprolactone. The empirical molecular formula of the polymer is (C2H2O2)m(C6H10O2)n.

    MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture is available undyed and dyed with D&C Violet #2

    MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture contains Triclosan, a broad spectrum antibacterial agent, ranging between 77 – 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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