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510(k) Data Aggregation

    K Number
    K150717
    Device Name
    Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron
    Manufacturer
    M/s. Meril Endo Surgery Private Limited
    Date Cleared
    2015-10-14

    (209 days)

    Product Code
    GAM,NEW
    Regulation Number
    878.4493
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron

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

    MEGASORB Absorbable Polyglycolic Acid Surgical Sutures are indicated for use in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological procedures.

    MITSU suture is intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.

    MITSU FST suture is indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. MITSU FSTTM suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.

    FILAX YN sutures are indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

    FILAPRON dyed / undyed sutures are intended 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

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for several surgical sutures. It does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. The document mainly states that the devices (MEGASORB, MITSU, MITSU FST, FILAXYN, FILAPRON) are substantially equivalent to legally marketed predicate devices and outlines their indications for use.

    Therefore, I cannot provide the requested information based on the provided text.

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