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510(k) Data Aggregation

    K Number
    K071776
    Device Name
    ANEUROPLASTIC, MODEL 43-1290
    Manufacturer
    Codman & Shurtleff, Inc.
    Date Cleared
    2007-07-26

    (27 days)

    Product Code
    JXH
    Regulation Number
    882.5030
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    K873688,K033382
    Why did this record match?
    Reference Devices :

    K873688, K033382

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

    Aneuroplastic® is indicated for the reinforcing and encapsulating of cerebral aneurysms.

    Device Description

    Aneuroplastic® is a self-curing methylmethacrylate (MMA) resin for reinforcing and encapsulating cerebral aneurysms. The following modifications are being made: A change is being made to the formulation of the liquid component and the Instructions for Use (IFU) is being updated.

    AI/ML Overview

    This document is a 510(k) summary for a medical device (Aneuroplastic®) and an FDA clearance letter. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The 510(k) submission process for this type of device (Methyl Methacrylate (MMA) for reinforcing and encapsulating cerebral aneurysms) primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical performance studies with acceptance criteria.

    Therefore, I cannot provide the requested information from the given input. The document focuses on regulatory classification, intended use, and the basis for substantial equivalence, which is typically through demonstrating similar technological characteristics to existing devices.

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