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510(k) Data Aggregation

    K Number
    K240506
    Device Name
    KARL STORZ Holders
    Manufacturer
    KARL STORZ Endoscopy America, Inc
    Date Cleared
    2024-10-22

    (244 days)

    Product Code
    OCV, GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KARL STORZ Holders are manually operated surgical devices intended to hold endoscopes (such as arthroscopes, etc) and accessories during general and neurologic diagnostic and therapeutic procedures.
    Device Description
    The KARL STORZ Holder is a manually operated surgical instrument intended to hold scopes (such as endoscopes, arthroscopes, etc) in a desired position during diagnostic, therapeutic, and surgical procedures (including neurologic procedures). The holder is manufactured from Stainless Steel and functions by the user manually tightening or loosening a knob, which opens and closes around a surgical scope. The device is intended to attach to the several KARL STORZ holding systems, which are a Class 1, table-mounted, mechanical and electromechanical holding arms that have many general surgical functions in addition to scope holding; it can also be used for instrument holding, retraction, and positioning.
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    K Number
    K232405
    Device Name
    ENDOFIX EXO
    Manufacturer
    AKTORmed GmbH
    Date Cleared
    2024-04-25

    (259 days)

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

    OCV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENDOFIX EXO is indicated for use in interventions where a rigid endoscope is indicated for use. The device is intended to hold and position a rigid endoscope / exoscope during general and neurological diagnostic and therapeutic procedures.
    Device Description
    The ENDOFIX EXO is a manually operated surgical device intended to hold endoscopes during general and neurological diagnostic and therapeutic procedures. It emulates an arm which is capable of guiding and positioning an endoscopic camera with several degrees of movement. lt ensures stable and sensitive positioning of the endoscope and allows the surgeon to work one-handed and/or two-handed. The system provides surgeons with a stable and rocksteady field of vision, even in extreme endoscopic positions. The wide scope of movement provides surgeons with full visibility of the situs. The ENDOFIX exo can be used with both, an endoscope and exoscope. An integrated DEACTIVATION PUSHBUTTON permits manual movement of the ENDOFIX EXO at the push of a button. In order to reposition a guided endoscopic camera, the ENDOFIX EXO is unlocked by a sterilizable CONTROL at the push of a button. The ENDOFIX EXO is operated by unlocking all 6 axes and subsequent manual positioning using the CONTROL. As soon as the button on the CONTROL is released, all 6 axes are locked again. Despite its large scope of movement, the ENDOFIX EXO is light-weight and compact and is fastened directly to the OR table by means of a quick-acting clamp. Thus, repositioning with reference to the patient is not necessary even if the OR table is moved in the meantime. On the rigid endoscope, there is a camera linked that sends a video to a monitor. Endoscope and camera as well as the monitor are not part of the ENDOFIX EXO. To allow the surgeon to convert to an open surgery in case of an emergency, the ENDOFIX EXO can be completely mounted or removed by a quick fastener. During use, the ENDOFIX EXO is covered with a STERILE COVER. The ENDOFIX EXO can be removed from the OR table and stored on the TROLLEY.
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    K Number
    K190576
    Device Name
    WalterLorenz Surgical Assist Arm Scope Holder
    Manufacturer
    Biomet Microfixation
    Date Cleared
    2019-06-05

    (91 days)

    Product Code
    OCV, GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WalterLorenz Surgical Assist Arm Scope Holder is a manually operated surgical device intended to hold scopes (such as endoscopes, arthroscopes, etc) and accessories during general diagnostic procedures. The device is also intended to hold endoscopes during diagnostic and therapeutic neurologic procedures.
    Device Description
    The WalterLorenz Surgical Assist Arm Scope Holder is a manually operated surgical instrument intended to hold scopes (such as endoscopes, etc) in a desired position during diagnostic, therapeutic, and surgical procedures (including neurologic procedures). The holder is manufactured from Stainless Steel and functions by the user manually tightening or loosening a knob, which opens and closes around a surgical scope. The device is intended to attach to the WalterLorenz Surgical Assist Arm, which is a Class 1, table-mounted, electromechanical holding arm that has many general surgical functions in addition to scope holding; it can also be used for instrument holding, retraction, and positioning.
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    K Number
    K102179
    Device Name
    ENVIEW (TM)
    Manufacturer
    CAREFUSION 2200
    Date Cleared
    2010-12-02

    (121 days)

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

    OCV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EnView™ camera controller is intended for use by surgeons and their designees to hold rigid endoscopes with diameters from 5 - 10mm during diagnostic and therapeutic surgical procedures. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, hernia repair, fundoplication, splenectomy, appendectomy, hemicolectomy, sympathectomy, lymph node dissection, hysterectomy, gastric banding, gastric bypass, nephrectomy, radical prostatectomy.
    Device Description
    The EnView™ camera controller is a manually operated mechanical surgical device. It is designed to hold an endoscope during diagnostic and therapeutic surgical procedures. A surgeon can, with one hand, position and reposition the placement of an endoscope during a surgical procedure by simple movements of a control handle. This camera controller eliminates the need for the surgeon to continually hold the endoscope during a surgical procedure.
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    K Number
    K093616
    Device Name
    V. MUELLER CAMERA CONTROLLER WITH STORAGE CART
    Manufacturer
    CAREFUSION 2200
    Date Cleared
    2009-12-23

    (34 days)

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

    OCV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The V. Mueller® Camera Controller is intended for use by surgeons for holding rigid endoscopes with diameters from 5 - 10 mm during diagnostic and therapeutic surgical procedures. The system includes a storage cart to be used for setup, storage, and transport of the device.
    Device Description
    The V.Mueller Camera Controller with Storage Cart is a manually operated, mechanical surgical device. The instrument provides for the one handed control for the positioning/repositioning of an endoscope during surgical procedures. The V.Mueller Camera Controller eliminates the need for the surgeon or assistant to continuously hold the endoscope during surgical procedures. The system includes a storage cart to be used for setup, storage, and transport of the device.
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    K Number
    K992006
    Device Name
    NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33
    Manufacturer
    INTEGRA NEUROCARE LLC.
    Date Cleared
    1999-08-17

    (63 days)

    Product Code
    OCV, GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Neuroview® Instrument Holder (Model: 300-33) is intended for use in holding Neuro Navigational Neuroview Endoscopes in a desired position over the patient during diagnostic and therapeutic procedures.
    Device Description
    The Neuroview Instrument Holder, Model 300-33, is a reusable, stainless steel accessory used to hold currently marketed Neuro Navigational Endoscopes. The holder consists of a rail clamp, adjustable stainless steel rods, toggle clamps, and an instrument clamp. This Instrument Holder, as well as the predicate devices, includes a one-piece design that is completely stable when used to position an instrument. The arms contain adjustable stainless steel clamps and holders that will adapt to any operating room table and hold any Neuro Navigational Endoscope. The holder can be positioned over the patient and locked into place to facilitate accurate Endoscope manipulation and instrument passage. The Instrument Holder, as well as the predicates accessory devices, is sold non-sterile and autoclavable for rapid operating room preparation. This Instrument Holder is intended to hold the Neuroview Endoscope in place. It has no direct contact with the patient. The only important performance aspect of the Instrument Holder is that it maintains its position once it has been positioned and tightened in place.
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    K Number
    K990334
    Device Name
    KSEA ENDOSCOPE HOLDER
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1999-03-22

    (47 days)

    Product Code
    OCV, GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This instrument is a manually operated surgical devices intended for Indications for Use: This mistiument is a manadiy operation soopes during diagnostic and therapeutic neurologic procedures.
    Device Description
    Endoscope Holder
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    K Number
    K971584
    Device Name
    CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)
    Manufacturer
    CLARUS MEDICAL SYSTEMS, INC.
    Date Cleared
    1997-05-23

    (23 days)

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

    OCV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model 2127-900 Series Endoscope Adapter is an accessory for the Clarus Medical Systems Model 2127 Endoscope. It is intended to be reusable. It is used to temporarily clamp or hold the endoscope when mounting to an airway catheter. MOUNT AND 450 ENDOSCOPE ACCESSORY TEST PORARILY 00 USED AIRWAY CATHETER APPRODUATE TOGETHER ENDOSECHE ADD AN
    Device Description
    The Model 2127-900 Series Endoscope Adapter is a machined or molded plastic piece used to hold an endoscope and airway catheter together. The endoscope adapter has a machined or molded tapered hub designed to fit firmly into the proximal end of various airway catheters. Additionally the endoscope adapter has a central hole designed to fit the outside diameter of the shaft on the appropriate legally marketed Clarus Model 2127 Endoscope.
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    K Number
    K960068
    Device Name
    SH-1 SURGICAL HOLDER FOR TELESCOPE
    Manufacturer
    OLYMPUS AMERICA, INC.
    Date Cleared
    1997-05-05

    (486 days)

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

    OCV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Olympus SH-1 Surgical Holder for Telescope can be utilized for the manipulation and positioning of a telescope during laparoscopic procedures.
    Device Description
    Not Found
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