Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K183171
    Device Name
    ScopeSeal Duodenoscope Protective Device
    Manufacturer
    GI Scientific LLC
    Date Cleared
    2019-10-08

    (326 days)

    Product Code
    ODB, FDT, FEI
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When properly installed: (i) the ScopeSeal® Duodenoscope Protective barrier at the scope's distal end to significantly reduce the level of contamination of the distal end during use and prior to reprocessing, and (ii) the ScopeSeal®'s working channel also provides a protective barrier sealing the duodenoscope's elevator area during use, and (iii) the ScopeSeal® device provides an additional protective benefit after use when kept in place during the ScopeSeal Pre-Cleaning Procedure™ performed after use. The ScopeSeal® is compatible for use with the Olympus Duodenoscope Model TJF-Q180V.
    Device Description
    The GI Scientific ScopeSeal® Duodenoscope Protective Device is provided as a sterile, single-use device that attaches to the distal end of a duodenoscope. When properly installed the device creates a protective barrier or shield that seals the distal end of the duodenoscope to protect it from contamination during the procedure. The device is designed to preserve the mechanical and optical functionality of the duodenoscope. The ScopeSeal® Duodenoscope Protective Device includes a flexible Working Channel Extension™ that seals against the end of the duodenoscope's working channel, providing a sealed, passageway from the end of the duodenoscope's working channel through the ScopeSeal® device's working channel extension and out to the patient's gastrointestinal tract. This element of ScopeSeal®'s design allows instruments to be passed down the duodenoscope's working channel, through the ScopeSeal® device's Working Channel Extension™, and out to the patient's gastrointestinal tract, without instruments coming into contact with the duodenoscope's elevator, effectively sealing over the elevator area of the duodenoscope. The ScopeSeal® allows passage of device up to 10.7Fr (3.5mm) in diameter.
    Ask a Question
    K Number
    K153698
    Device Name
    LumenR Tissue Retractor System
    Manufacturer
    LumenR, LLC
    Date Cleared
    2016-04-19

    (118 days)

    Product Code
    ODB, FED, GAD
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LumenR Tissue Retractor System is indicated for use in conjunction with an endoscope for tissue or foreign body manipulation and/or where multiple removal and reinsertions of the endoscope are required.
    Device Description
    The LumenR Tissue Retractor System (LRS) is an intra-luminal surgical device facilitating tissue manipulations inside the lumen.. It is a non-powered, handmanipulated device. The LumenR Tissue Retractor System includes a LumenR Instrument Guide (LIG) and LumenR Cannula Retractor (LCR). The LIG and LCR are single use devices that are provided non-sterile. LumenR Cannula Retractor (LCR) is provided in various Lengths and Diameters in order to accommodate individually variable natural body lumens. The LumenR Cannula Retractor (LCR) comprises of (1) Handle (proximal end located outside of a patient), (2) Retractor (chamber-like expandable retractor located at the device's distal end), and (3) flexible Shaft (located in between the handle and a Retractor). LumenR Instrument Guide (LIG) is an instrument guide or a hollow conduit for existing flexible endoscopic instruments, for example, tissue forceps, which helps guide the instrument towards the target tissue, but doesn't directly interact with the tissues.
    Ask a Question
    K Number
    K080550
    Device Name
    MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22
    Manufacturer
    MINOS MEDICAL
    Date Cleared
    2008-06-10

    (103 days)

    Product Code
    ODB
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Megachannel Endoscopic Overtube is indicated for use in conjunction with an endoscope for tissue or foreign body manipulations and/or where multiple removal and reinsertions of the endoscope are required.
    Device Description
    The Megachannel Endoscopic Overtube is a disposable flexible PVC tube that is to be used with an endoscope. The overtube includes a proximal handle with insufflation sealing cap that accommodates a standard 12.8 mm diameter colonoscope. A removable introducer plug is attached to the distal tip to facilitate the introduction of the overtube through the gastrointestinal tract.
    Ask a Question
    K Number
    K060475
    Device Name
    EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Date Cleared
    2006-03-17

    (22 days)

    Product Code
    ODB, EOQ, ITX
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures as follows: Clinical Application: Trans-esoph. (non-Card.), Other (spec.) Mode of Operation: B, M, Combined (Spec.) B+M, Other (Spec.) Note 1 Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, and imaging for guidance of biopsy. Note 2: Specification for "Other" (1) the airways and tracheobronchial tree. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application: Trans-esoph. (non-Card.), Other (spec.) Mode of Operation: B, M, Combined (Spec.) B+M, Other (Spec.) Note 1 Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, and imaging for guidance of biopsy. Note 2: Specification for "Other" (1) the airways and tracheobronchial tree.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1