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510(k) Data Aggregation

    K Number
    K093783
    Device Name
    INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT
    Manufacturer
    INNOVIA, LLC
    Date Cleared
    2010-08-23

    (257 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVIA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Innovia InnoPort™ Laparoscopic Access Device is a sterile, single use device intended for use as a multiple instrument and/or camera port during minimally invasive laparoscopic abdominal surgery.
    Device Description
    The InnoPort Laparoscopic Access Port is a sterile, single use laparoscopic access device comprised of flexible polymer and a rigid plastic plate. The InnoPort forms a truncated cone approximately 5.0 centimeters long (not including instrument ports), with three individual laparoscopic instrument ports at the larger end. A fourth port connects to the infor system to provide intra-abdominal pneumoperitoneum, and a fifth port coulties of the insunprocedural smoke removal. The instrument ports are designed to accommodate 5 mm dinerer laparoscopic instruments while allowing full maneuverability without loss of neumperioneum. The complete device is designed to be inserted through a single incision into the abdominal cavity for the duration of surgery.
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    K Number
    K060151
    Device Name
    ORBITAL TISSUE EXPANDER (OTE)
    Manufacturer
    INNOVIA, LLC
    Date Cleared
    2006-08-08

    (200 days)

    Product Code
    NFM
    Regulation Number
    886.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVIA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OTE would be used in the case of congenital anophthalmia, congenital microphthalmia or acquired anophthalmia from, e.g., childhood ocular tumors or trauma.
    Device Description
    The integrated orbital tissue expander (OTE), consisting of a flexible "balloon/expander" is held in place by means of a titanium fixation plate that is anchored to the lateral orbital wall by screws. A slotted arm attached to the fixation plate, extends through a slot that is formed within the OTE. The OTE can be manually moved along the shaft of the fixation plate to achieve optimal central position in an expanding socket. A 30 gauge disposable hypodermic needle connected to a 1 cc disposable syringe filled with sterile saline is inserted into the OTE through an injection port. Inflation of the OTE will effect pressure on the orbit of the patient.
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