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510(k) Data Aggregation

    K Number
    K122411
    Device Name
    J-SCOPE SYSTEM
    Manufacturer
    Date Cleared
    2013-02-11

    (187 days)

    Product Code
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MYELOTEC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The J-Scope System is an endoscopic device intended to be used by physicians for introduction of fluids to assist in visualization of intra-articular structures for arthroscopic diagnosis, as well as for surgical procedures using a second J-Scope or other arthroscopic device. It is indicated for use in the shoulder, hip, wrist, ankle, knee, and elbow joints.
    Device Description
    The J-Scope Tissue Visualization & Assessment Mini-Cannula Kit is a single-use, disposable small diameter, 14-gauge needle mini-cannula device which, when coupled with the J-Scope semi-rigid or flexible Arthroscope, provides convenient and precise arthroscopic visualization of both major and minor joints. The micro-invasive design of the system allows the procedure to be performed comfortably with the patient under local anesthesia.
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    K Number
    K980734
    Device Name
    MYELOTEC VIDEO GUIDED CATHETER
    Manufacturer
    Date Cleared
    1998-08-11

    (167 days)

    Product Code
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MYELOTEC, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    when used with a fiberoptic endoscope, this device can be used in the lumbar and sacral spine for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications.
    Device Description
    The MYELOTEC VIDEO GUIDED CATHETER (VGC) consists of a flexible double lumen catheter, steering handle and associated ports for access to the lumens. The catheter has a built in steering mechanism that allows for guiding the soft tip through the epidural space and soft tissues for optimal access to the source of distress. Each lumen is one (1) mm in diameter. The design allows the use of a flexible fiber optic endoscope for visual examination of the area and surrounding tissues at the distal end of the catheter. This visual examination then allows the physician to diagnose the potential causes of neural distress and pain. The port on the second lumen allows the injection of saline to expand the space and expose the source of distress for viewing and treatment. The port also facilitates the connection of syringes to deliver physician selected therapeutic agents as appropriate to their diagnosis.
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    K Number
    K960194
    Device Name
    MYELOTEC MYELOSCOPE
    Manufacturer
    Date Cleared
    1996-09-04

    (232 days)

    Product Code
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MYELOTEC, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Myeloscope is intended to be used by physicians for the illumination and The Mydlescope is intenthe epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease.
    Device Description
    The Myelotec Myeloscope is a flexible fiberoptic system that includes a video guided catheter that allows steering of the fiberoptic scope. The fiberoptic scope is a reusable device that is supplied non-sterile with instructions for cleaning, sterilization and re-use. The video guided catheter is a sterile, disposable device.
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