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510(k) Data Aggregation

    K Number
    K014060
    Device Name
    MICROAIRE 1000E SYSTEM
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, INC.
    Date Cleared
    2002-03-05

    (85 days)

    Product Code
    HBE, HBC
    Regulation Number
    882.4310
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROAIRE SURGICAL INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroAire® 1000E System is indicated for use in cutting, sawing, drilling, reaming, wire driving, pinning, screw driving, decorticating, shaping and manipulation of bone and other bone related tissue in a variety surgical procedures. The applications include ENT, maxilliofacial, neurological, oral, orthopedic, plastic, podiatric and spinal surgery.
    Device Description
    The MicroAire® 1000E System consists of an electric power supply, powerconnecting cable(s), a foot and/or hand lever power activation control, modular and unitized handpieces, modular head assemblies and accessories.
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    K Number
    K981922
    Device Name
    LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, INC.
    Date Cleared
    1998-12-10

    (192 days)

    Product Code
    QPB, MUU, OPB
    Regulation Number
    878.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROAIRE SURGICAL INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroAire® PAD™ System is indicated for the removal of tissue or fluid from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.
    Device Description
    The MicroAire® PAD™ System consists of two primary components: a pneumatic or electric reciprocating handpiece and a disposable cannula with attached suction tubing. The disposable cannula with attached suction tubing connects to an external suction sources that is not part of the PAD™ System. A disposable cannula with attached tubing is also available with a syringe to facilitate manual suction. The pneumatic reciprocating handpieces operate with an air or nitrogen power supply. The handpieces are capable of driving the cannula through a stroke distance of 2.4-6mm (0.093-0.240in.) at a rate of 3500-4500 strokes per minute. The electric reciprocating handpiece is capable of driving a cannula through a stroke distance of 2.4mm (0.093in.) at a rate of 3500-4500 strokes per minute. The electric handpiece is powered and controlled by the MicroAire® Smartdrive™ electric console. The cannula is essentially a blunt tipped hollow tube comprised of stainless steel with an attached PVC suction tube and optional syringe. The cannula internal diameter is approximately 3mm and ranges from 26-33cm in overall length. Fluid and tissue is aspirated through windows located near the tip of the cannula when the tubing is connected to a suction source. The number of windows varies between 3-6 openings with window lengths from 7-10mm at 2mm in width.
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    K Number
    K973268
    Device Name
    MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, INC.
    Date Cleared
    1997-11-26

    (89 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROAIRE SURGICAL INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroAire PAD System is indicated for the removal of tissue or fluid from the body during general surgical procedures.
    Device Description
    The MicroAire® PAD™ System differs from the predicate devices in that it possesses a powered reciprocating cannula. The small (2-6 mm), rapid stroke of the PAD" cannula simulates the manual hand motion that the surgeon would use during aspiration with the predicate devices. Thus, use of the PAD" System does not raise safety and effectiveness issues that are significantly different from those of the predicate devices. At the same time, the powered cannula minimizes surgeon effort by reducing the amount of necessary arm motion. Furthermore, the slight reciprocating action of the PAD" System facilitates the passage of the cannula through tissue. When the reciprocating action is not activated by the surgeon, the PAD" device functions in an identical manner to the predicate devices.
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    K Number
    K955591
    Device Name
    MICROAIRE SMARTDRIVE SYSTEM
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, INC.
    Date Cleared
    1996-01-18

    (42 days)

    Product Code
    HWE
    Regulation Number
    878.4820
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROAIRE SURGICAL INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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