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510(k) Data Aggregation

    K Number
    K103508
    Device Name
    UNMIAX LAPAROSCOPIC INSTRUMENT
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Date Cleared
    2011-12-20

    (386 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIMAX MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Unimax Laparoscopic Instrument is a family of instruments which includes forceps, scissors, and probes which are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar electrosurgical cutting and/or coagulation.
    Device Description
    The Unimax Laparoscopic Instrument includes Grasping Forceps, Monopolar Scissors, and Monopolar Probe/Electrodes. The devices are disposable, single use, individually packaged devices that are composed of biocompatible materials. Scissors and forceps have a handle with rotating wheel attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and their generators. Probes/Electrodes have an insulated shaft with a thermally conductive metal tip electrode. The proximal end of the shaft is attached to a handle made of an injection molded, medical grade plastic.
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    K Number
    K112358
    Device Name
    UNIMAX TROCAR SYSTEM
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Date Cleared
    2011-10-17

    (62 days)

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

    UNIMAX MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Unimax Trocar System, Model: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar, Hasson Trocar, Dilating Trocar, Secondary Trocar, and Thoracic Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
    Device Description
    The Auto-locking Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Auto-locking Trocar is available from 3-15mm. The cannula assembly has a universal seal, a valve, and a stopcock. This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered. The cannula assembly has universal seal and stopcock. The Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Bladeless Trocar is available from 3-15mm The cannula assembly (10mm and 12mm type) has a universal seal, a valve, and a stpcock. The cannula assembly (5mm type) has a stopcock. The Visible Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Visible Trocar is available from 5-15mm. Visible Trocar allows direct visualization of the abdominal wall layers when the trocar is traversed, which offers a safe and rapid option of primary trocar. The cannula assembly has a universal seal, a valve, and a stopcock. The Hasson Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Hasson Trocar is available from 3-15mm. This device has a blunt tip, which is designed for open Laparoscopy. The cannula assembly has a fixation device, a universal seal, a valve, and a stopcock. The Dilating Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoacopic instruments. The Dilating Trocar is available from 3-15mm. This device has a non-bladed conical tip which offers enhanced security to enter the abdomen. The cannula assembly has two-ply of seal and stopcock. There is a built-in universal seal. The Secondary Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Secondary Trocar is available in 2 different lengths: 5mm/7cm and 5mm/10cm. This device has a non-bladed conical tip which offers enhanced security to enter the abdomen. The cannula assembly has two-ply of seal and stopcock. The Thoracic Trocar consists of a blunt-tipped obturator and a threaded cannula. It is designed for instrument stabilization and also protect against foreign materials entering the chest cavity. Once inserted into the chest, the Thoracic Trocar must be turned clockwise until it is securely seated in the tissue. There are four types of Thoracic Trocars: 6mm/7cm, 11mm/7cm, 13mm/7cm, and 15mm/7cm.
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    K Number
    K111622
    Device Name
    UNIMAX ANTI-FOG SOLUTION
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Date Cleared
    2011-09-09

    (91 days)

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

    UNIMAX MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Unimax Anti-Fog Solution is intended to be used to prevent "fogging" (caused by condensation) on the lenses of endoscopic/laparoscopic instruments which are likely to fog during use.
    Device Description
    The Unimax Anti-Fog Solution is a clear / colorless, water soluble solution. The model with alcohol is comprised of DPGMME (=2%), Isopropyl alcohol (=6%), and Deionized water (=92%), while the model without alcohol is comprised of DPGMME (=2%) and Deionized water (=98%). Unimax Anti-Fog Solution functions by reducing the surface tension of water, thus preventing water droplets (fog) from forming on the lenses of endoscopic / laparoscopic instruments during use. This solution is bottled in a volume of 6cc's in a 10cc clear plastic dropper bottle. Included in the tyvek pouch packaging of this product is a 4.5*4.5*0.5 (L*W*H) adhesive backed, non-abrasive, x-ray detectable radiopaque/nonradiopaque, polyurethane foam pad for applying the product to endoscopic / laparoscopic lenses. This product is sold sterile to healthcare professionals only.
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    K Number
    K111441
    Device Name
    UNIMAX VERESS NEEDLE
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Date Cleared
    2011-08-19

    (87 days)

    Product Code
    HIF, FHO
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIMAX MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Unimax Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
    Device Description
    The Unimax Veress Needle is a sterile and single-use product. It incorporated a spring loaded blunt stylet mechanism similar to the needle. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Veress Needle, available in 120mm and 150mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.
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    K Number
    K103509
    Device Name
    UNIMAX SUCTION IRRIGATION SET
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Date Cleared
    2011-05-19

    (171 days)

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

    UNIMAX MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Unimax Suction Irrigation Set is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic gynecologic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
    Device Description
    The Unimax Suction Irrigation Set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver-sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site. The suction irrigation set consists of a hand piece equipped with two trumpet style valves, a probe, and connecting lines of tubing, one set designed to a supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure. The hand piece of the suction irrigator is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. It is a single use, disposable device and is sold sterile.
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    K Number
    K103510
    Device Name
    UNIMAX SPECIMEN RETRIEVAL SYSTEM
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Date Cleared
    2011-05-06

    (158 days)

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

    UNIMAX MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Unimax Specimen Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.
    Device Description
    The Unimax Specimen Retrieval System is a sterile and single-use specimen container designed for use in retrieving specimens during endoscopic surgery. The Unimax Specimen Retrieval System is supplied in a dispending tube for ease of insertion through a standard 10, 11 or 12mm trocar sheath.
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