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510(k) Data Aggregation

    K Number
    K083788
    Device Name
    ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR
    Manufacturer
    ENDO OPTIKS, INC.
    Date Cleared
    2009-03-03

    (74 days)

    Product Code
    EYB
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDO OPTIKS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stonebuster Endoscopic System for Stone Removal (SESSR) Catheter for Endoscopy is intended to provide access to the ureteral canal and to be used to guide the currently available visualization devices and accessory devices such as bionsy forceps, cytology brushes, stone retrieval baskets, etc. during endoscopic procedures. The indications for use of the catheter are in urological applications.
    Device Description
    The Stonebuster Endoscopic System for Stone Removal (SESSR) Delivery Catheter is a sterile, single-use device comprised of one main component: a flexible triple lumen delivery catheter with three Luer-Lock delivery ports. This device is intended to provide access to the ureteral canal and to be used to guide the currently available visualization devices and accessory devices such as biopsy forceps, cytology brushes, stone retrieval baskets, etc. during endossopic procedures. The SESSR Delivery Catheter is introduced into the desired anatomical location through the SESS sheath with a minimum working channel diameter of 4.3mm. The distal tip of the SESSR is straight or benefit at minimum of 6.5 mm from the distal tip of 10 degrees providing the physician with (when using visualization devices) a wider field of view.
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    K Number
    K042918
    Device Name
    MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2
    Manufacturer
    ENDO OPTIKS, INC.
    Date Cleared
    2004-11-22

    (31 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDO OPTIKS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ophthalmic laser endoscope is indicated for intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, proliferative retinopathies, visualization of the internal ocular structures in retinal detachment, and for visualization of the anterior segment which do not allow a posterior view. Glaucoma This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic medications, or previous laser photocoagulation, or trabeculectomy and other filtering procedures, or other cyclodestructive procedures. The endophotocoagulation of ciliary processes under direct endoscopic view is a recognized procedure and has been demonstrated to be effective in the treatment of glaucoma. Vitreoretinal Surgery The endoscopically controlled endophotocoagulation that is possible with the MicroProbe is also useful for endophotocoagulation: - To produce chorioretinal scar around retinal breaks or retinotomy sites - To perform intraoperative panretinal photocoagulation (PRP) in proliferative retinopathies - To perform intraoperative retinal photocoagulation on a scleral buckle - To perform intraoperative photocoagulation around focal neovascularization
    Device Description
    The Endo Optiks E2 MicroProbe™ is the principal component in a new portable laser and endoscopy system. The complete system consists of the therapeutic laser, the endoscope, the monitor and the footswitch. This compact unit creates the opportunity to simultaneously image and photocoagulate the ciliary processes through a corneal incision. It is especially indicated for the safe and effective treatment of glaucoma in combination with cataract surgery. Important vitreo-retinal applications can be realized. It can be used for the contact and non-contact excision, hemostatis, incision and vaporization of soft tissue. The E2 MicroProbe is a modification to the packaging of the original MicroProbe.
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    K Number
    K003151
    Device Name
    MICROPOBE SERIES OF LASERS AND ACCESSORIES
    Manufacturer
    ENDO OPTIKS, INC.
    Date Cleared
    2001-01-08

    (90 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDO OPTIKS, INC.

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