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510(k) Data Aggregation

    K Number
    K231622
    Device Name
    REGER Nebulizer Irrigation Cannula
    Date Cleared
    2023-09-29

    (119 days)

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

    REGER Medizintechnik, GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The REGER Nebulizer Irrigation Cannula is indicated for use in patients undergoing a laparoscopic procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to lavage blood and tissue debris from the surgical site.
    Device Description
    The REGER Medizintechnik Nebulizer Irrigation Cannula is a sterile, single use stainless steel cannula with a polymer handle that is intended to nebulize irrigation fluids into the body during laparoscopic procedures. The sterile irrigation fluid is delivered from an injection pump (not provided) through the polymer tubing and into the stainless-steel shaft. The shaft has internal mechanics that deliver the fluid as microscopic droplets in a fine mist. The REGER Medizintechnik Nebulizer Irrigation Cannula is designed with a precision orifice at the tip for the deployment of a precise nebulized spray of irrigation solution into the laparoscopic cavity. The REGER Medizintechnik Nebulizer Irrigation Cannula is straight and measures between 243-245 mm from Tip to the end of the handle with a shaft diameter ranging from 3.0 - 8.0 mm. The orifice at the head of the cannula shaft ranges in diameter of 0.17mm to 0.2mm. The REGER Medizintechnik Nebulizer Irrigation Cannula also contains a 10' flexible 3.15mm outer diameter polymer tube at the handle end for attachment to attached to irrigation fluid injection pump (not provided) via a luer fitting.
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    K Number
    K081218
    Device Name
    BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST
    Date Cleared
    2008-07-21

    (82 days)

    Product Code
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    IT-V MEDIZINTECHNIK, GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The function of the BellySTEP™ is for positioning of the lower abdomen of a patient during radiotherapy and diagnostics. The function of the HeadSTEP™ is for fixation and (re)positioning of the head and neck area of the patient during radiotherapy and diagnostics. The function of the BreastSTEP™ is for positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics. The function of the ProSTEP™ is for positioning of hip and lower extremities of a patient for radiotherapy. The function of the WingSTEP™ is for positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics. The function of the iCAST™ thermoplastic materials are for use in retaining and reproducing a patient's position during radiation therapy.
    Device Description
    BellySTEP™: The BellySTEP™ is made for the positioning of the lower abdomen of a patient. The BellySTEP™ Baseplate enables the use of Inter-changeable inserts. It is made of Polyethylene Foam and covered with artificial leather. HeadSTEP™: The HeadSTEP™ iFRAME based immobilization system guarantees high precision and facile repositioning in routine cranial as well as head and neck immobilization. BreastSTEP™: The BreastSTEP™ enable positioning, repositioning and high comfort in the routine breast and thorax fixation. ProSTEP™: The ProSTEP™ was designed to improve the accuracy of the positioning of the hip and the lower extremities. WingSTEP™: The WingSTEP™ enable positioning, repositioning and high comfort in the routine breast and thorax fixation. iCAST™: The iCAST™ Thermoplastic is a non-sticky low temperature thermoplastic sheet material for the production of immobilization masks (head, head/neck) for patients undergoing radiation therapy treatment.
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    K Number
    K971001
    Device Name
    AUTIMO
    Date Cleared
    1997-06-13

    (86 days)

    Product Code
    Regulation Number
    892.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIZINTECHNIK, GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 2-D AUTIMO system is intended for the fabrication and positioning in radiotherapy of indivdualized (irregular) shielding blocks.
    Device Description
    The AUTIMO 2-D model is a computer-controlled cutting tool to produce customized shielding blocks for use in radiotherapy. The computer accepts files from existing treatment-planning system operating on a LAN. The GE-Target, Siemens Helax, and Theratronics Theraplan systems are examples of such treatment-planning software. The computer interprets the files from the planning system and communicates with the AUTIMO device through a serial port. The 2-D model allows automatic hot-wire-cutting of styrofoam molds such as lung blocks and irregular sections.
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