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510(k) Data Aggregation

    K Number
    K252820
    Device Name
    PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)
    Manufacturer
    Internacional Farmacéutica S.A de C.V
    Date Cleared
    2025-10-03

    (29 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K072859
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Atramat® PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.

    Device Description

    The subject devices, ATRAMAT® PGLA90 (Calypso/Odysseus), are modifications to the previously cleared Atramat® PGLA90 Poly(glycolide-co-L-lactide) Surgical Suture (K072859). The predicate device is a synthetic, absorbable, sterile surgical suture composed of a copolymer of glycolide and L-lactide, which is indicated for soft tissue approximation.

    ATRAMAT® PGLA90 (Calypso/Odysseus) devices integrate the predicate suture into a metal part with a pre-tied knot mechanism. This modification changes the operating method from traditional hand-tying to a pre-tied knot closure.

    AI/ML Overview

    N/A

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