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510(k) Data Aggregation

    K Number
    K120605
    Device Name
    PERMACOL SURGICAL IMPLANT
    Manufacturer
    Covidien LLC
    Date Cleared
    2012-05-18

    (80 days)

    Product Code
    FTM,OXK
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K043366,K100261
    Why did this record match?
    Reference Devices :

    K043366, K100261

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

    Permacol™ Surgical Implant is intended for use as a soft tissue implant to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal, inguinal, diaphragmatic, femoral, scrotal, umbilical, incisional, parastomal hernias, muscle flap reinforcement and abdominal wall defects.

    Device Description

    Permacol ™ Surgical Implant is a sterile, off-white, moist, tough and flexible, fibrous flat sheet of acellular porcine dermal collagen and its constituent elastin fibers. Presented moist in sterile saline, Permacol ™ Surgical Implant is double vacuum packed and heat sealed peel-open aluminum foil (inner) and peel-open polyester/polyethylene (outer) pouches.

    AI/ML Overview

    The provided text is a 510(k) summary for the Permacol™ Surgical Implant, a surgical mesh device. The submission explicitly states that "No new performance data has been included in this submission." This means that the 510(k) relies on the substantial equivalence to a predicate device (Permacol™ Surgical Implant, K043366) and does not present new studies with acceptance criteria or device performance data for the current submission.

    Therefore, the requested information cannot be filled out from the provided document as it does not contain details of an acceptance criteria study for the current device submission.

    However, based on the principle of substantial equivalence for a 510(k) submission, the performance of the predicate device (Permacol™ Surgical Implant, K043366) would have been used to establish its safety and effectiveness, and the current device is deemed to meet those same performance characteristics due to its identical nature. The document explicitly states: "Permacol TM Surgical Implant is identical to the predicate device, Permacol TM Surgical Implant, K043366, in terms of its technological characteristics." and "No material changes are proposed in this submission."

    Since no new performance data or study is presented in the provided K120605 submission, the table and other details related to a specific study cannot be extracted.

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