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510(k) Data Aggregation

    K Number
    K974561
    Device Name
    MOISTAIR FLUID AIR TUBING SET
    Manufacturer
    AMERICAN MEDICAL DEVICES, INC.
    Date Cleared
    1998-02-19

    (76 days)

    Product Code
    KYG, FRN
    Regulation Number
    886.4360
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For infusion of fluid and air during vitrectomy.
    Device Description
    During a vitrectorny, it is necessary to irrigate balanced salt solution (BSS) into the eye to replace the natural vitreous. If a retinal hole is present, the surgeon must then replace the balanced salt solution (BSS) with air to prevent the fluid from remaining under the retina. One of the problems associated with fluid/air exchange is development of cataracts. The Moistair™ Tubing Set humidifies the dry air prior to introduction into the eye. In order to humidify the air, 1 cc of balanced salt solution (BSS) is injected into the injection port on the humidifying filter prior to use.
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    K Number
    K971853
    Device Name
    ENDOVIEW SPPHIRE LENS SET
    Manufacturer
    AMERICAN MEDICAL DEVICES, INC.
    Date Cleared
    1997-08-06

    (78 days)

    Product Code
    HJK, 86H
    Regulation Number
    886.1385
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For magnification during vitreoretinal surgery.
    Device Description
    The Endoview™ Sapphire Contact Lens Set consists of one sterilization container, one lens ring (either infusion or non-infusion), and one each of the following lenses: Plano Concave, Symmetric Concave-Concave, Asymmetric Concave, Prism 15° - Concave, Prism 30° Concave, and a Prism Concave-Concave Lens. The lenses, rings and sterilization container may be sold separately or as a set. During vitreoretinal surgery, the surgeon requires the aid of a contact lens in order to visualize the posterior segment of the eye. First, the ring is sewn onto the sclera to hold the lens in place on the cornea. The customer has the option of choosing a ring with an infusion port, which eliminates the need for the surgeon to constantly place irrigant on the corneal. Once the ring is in place, the surgeon places one of the lenses in the ring in order to visualize the posterior segment of the eye. The surgeon changes the lenses during the case depending on where visualization is required.
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    K Number
    K970882
    Device Name
    ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)
    Manufacturer
    AMERICAN MEDICAL DEVICES, INC.
    Date Cleared
    1997-06-24

    (106 days)

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

    AMERICAN MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For illumination and irrigation/aspiration during surgery.
    Device Description
    The American Medical Devices, Inc 19 and 20 ga. Endolight™ End Irrigating Endo-Illuminators are for illumination and irrigation during surgery. It consists of a stainless steel needle, delrin handpiece, PMMA fiberoptic fiber with plastic cladding, aluminum connector, and silastic tubing with luer lock connector. It connects to any conventional light source via an aluminum accessory adapter, which is packaged separately. This device also connects to any standard syringe with a male luer lock. The surgeon can then use the device to irrigate and aspirate while illuminating.
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    K Number
    K970873
    Device Name
    ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)
    Manufacturer
    AMERICAN MEDICAL DEVICES, INC.
    Date Cleared
    1997-05-20

    (71 days)

    Product Code
    HMX
    Regulation Number
    886.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For irrigation/aspiration during eye surgery
    Device Description
    The American Medical Devices, Inc 19 and 20 ga. Endosoft™ Soft Tip Needles are for irrigation/aspiration during eye surgery. The device consists of a stainless steel needle with a plastic luer lock on one end and a protruding piece of soft silastic tubing at the tip. This device connects to any conventional extrusion handpiece with a male luer lock adapter.
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    K Number
    K970875
    Device Name
    ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)
    Manufacturer
    AMERICAN MEDICAL DEVICES, INC.
    Date Cleared
    1997-05-20

    (71 days)

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

    AMERICAN MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For illumination during ophthalmic surgery
    Device Description
    The American Medical Devices, Inc., 19 and 20 ga. Endolight™ Fiberoptic Endo- Illuminators are for illumination during ophthalmic surgery. The device consists of a stainless steel needle with a delrin handpiece, PMMA fiberoptic fiber with plastic cladding and an aluminum connector. This device connects to any conventional light source via an aluminum accessory adapter, which is packaged separately.
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    K Number
    K970878
    Device Name
    ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT
    Manufacturer
    AMERICAN MEDICAL DEVICES, INC.
    Date Cleared
    1997-05-06

    (57 days)

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

    AMERICAN MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For illumination during surgery. Regular Monofilament - Inserts into any standard Fiberoptic Pic Set. Fine Monofilament - Inserts into any standard Fiberoptic Forceps.
    Device Description
    The American Medical Devices Endolight™ Regular and Fine Monofilaments are for illumination during surgery. The Regular Monofilament inserts into any standard pic set. The Fine Monofilament inserts into any standard fiberoptic forceps. These fibers allow the surgeon to use bi-manual technique during surgical procedures. The devices are identical except for the fact that the Regular Monofilament is a 19 ga. fiber and the Fine Monofilament is a 20 ga. fiber.
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