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510(k) Data Aggregation

    K Number
    K203226
    Device Name
    TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM
    Manufacturer
    Richard Wolf Medical Instruments Corporation
    Date Cleared
    2021-05-14

    (193 days)

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

    GCM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The products are used in invasive surgery or via natural orifices for diagnosis and therapy and serve to visualize the inside of the body. The products are used for interventions in different medical disciplines, such as surgery and laparoscopic interventions e.g. in urology and gynecology.
    Device Description
    The PANOVIEW Ultra telescopes (common name: telescopes) are rigid endoscopes which are used in invasive surgery or via natural orifices for diagnosis and therapy and serve to visualize the inside of the body. The products are used for interventions in different medical disciplines, such as surgery and laparoscopic interventions e.g. in urology and gynecology. The submitted devices can be grouped by working length (WL) and direction of view. The PANOVIEW Ultra telescopes (common name: telescopes) are rigid endoscopes with a fixed eyepiece, integrated light guide, optical system, cold light connector, with screw-on adapter for fiber light cables and with color coding ring for direction of view. The telescopes are constructed of a cladding tube, which is surrounded by a rigid sheath, a fixed eyepiece and an eyecup at the proximal end. Within the cladding tube, images are transferred via a rod lens system to the fixed eyepiece. Illumination is provided via light guide bundles connected to a light source. Visualization can directly be performed via the fixed eyepiece (direct visualization method) or alternatively via a monitor and user interface (indirect visualization method). For the second option, a camera must be attached to the fixed eyepiece and must be connected to a monitor.
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    K Number
    K083840
    Device Name
    MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE
    Manufacturer
    MSI MEDSERV INTERNATIONAL DEUTSCHLAND GMBH
    Date Cleared
    2009-09-28

    (278 days)

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

    GCM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rigid Endoscopes MSI MedServ International Deutschland GmbH rigid endoscopes and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs and canals.
    Device Description
    A rigid endoscope is a tubular endoscopic device with any of a group of accessory devices which attach to the endoscope and is intended to provide access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals. It is typically used with a Fiberoptic light source and carrier to provide illumination.
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    K Number
    K001217
    Device Name
    INSIDE VIEW
    Manufacturer
    MONADNOCK OPTICS, INC.
    Date Cleared
    2000-07-11

    (85 days)

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

    GCM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993103
    Device Name
    ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Date Cleared
    1999-12-10

    (85 days)

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

    GCM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The endoscopes serve to visualize the inside of the patient via natural or surgically generated access. For examination, diagnosis, and / or therapy by personnel trained and qualified in connection with endoscopically used accessories in various medical disciplines, such as surgery, urology, gynecology, and ENT.
    Device Description
    Rigid Endoscopes, 10mm diameter, Models 8934.431, 0°, 8934.432, 30°, and 8934.433, 50°
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    K Number
    K993445
    Device Name
    OMNISONIC ENDOSCOPIC DEFLECTOR
    Manufacturer
    OMNISONICS MEDICAL TECHNOLOGIES
    Date Cleared
    1999-12-06

    (55 days)

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

    GCM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OmniSonics Endoscopic Deflector is designed to assist in the placement and deflection of I he Onlinoomiss indoscopic Donector atheters and endoscopes used in surgical procedures in body cavities, hollow organs and canals. The OmniSonics Endoscopic Deflector is designed to be introduced through natural body openings, surgical incisions and through introducers, needles, trocars, catheters, sheaths and other devices with lumens having an inside diameter larger than the outside diameter of the OmniSonics Endoscopic Deflector shaft selected. The OmniSonics Endoscopic Deflector is sold sterile and is intended for single patient use. The OmniSonics Endoscopic Deflector is indicated for the following applications: Ureteroscopy Thoracoscopy Nasopharyngoscopy Sinuscopy General laparoscopy Urology Gynecology Bronchoscopy
    Device Description
    The OmniSonics Endoscopic Deflector assists in the delivery of small diameter flexible; instruments, catheters, probes, and endoscopes. The device deflects these instruments to aid in the direction and delivery of the product to a specific surgical site that is not in line with the axis of the instrument. The purpose of the OmniSonics Endoscopic Deflector is to provide a means to deliver small diameter instruments to areas that would be difficult to access with a straight instrument. The OmniSonics Endoscopic Deflector works in a similar fashion to steerable endoscopes. This instrument is different in that it only contains lumens for the introduction of ancillary instrumentation and does not possess an integral visualization system. The user must insert all of the additional capabilities desired through the OmniSonics Endoscopic Deflector central lumen. Products that are capable of working with the OmniSonics Endoscopic Deflector are flexible, malleable or bendable and must be capable of obtaining a bend radius of 30 mm or less. They must also have an outer diameter compatible with the inner diameter of the unit selected. The actual deflection produced at the end of the device will depend upon the stiffiess of the inserted instrument. The OmniSonics Deflector is constructed with the following major components: Outer sheath tube: A rigid, stainless steel tube that provides rigidity for insertion into the body Deflection tube: A flexible, polyurethane, kink resistant tube that bends when the deflection handle is activated. Deflection wire: A stainless steel wire that pulls the tip of the deflection tube to cause deflection. Deflection handle: An ABS handle that has mechanisms for rotation of the shaft, articulation of the deflection tube, movement of the inserted device in and out and sealing of the inserted device.
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    K Number
    K962393
    Device Name
    KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1996-09-17

    (89 days)

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

    GCM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KSEA Set for Endoscopic Assisted Intubation is designed to be used by qualified surgeons and physicians to view the larynx during intubation.
    Device Description
    The KSEA Set for Endoscopic Assisted Intubation is comprised of a Rigid Telescope and a BUMM Clip. KSEA Rigid Telescopes for Endoscopic Assisted Intubation are rigid, straight-shafted, panoramic telescopes which utilize Hopkins rod-lens technology. The KSEA BUMM Clip is used to secure the KSEA rigid telescope to a laryngoscope. The body contact portions of the KSEA Set for Endoscopic Assisted Intubation are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
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    K Number
    K950712
    Device Name
    PORTABLE ENDOSCOPY SYSTEM
    Manufacturer
    LASER-OPTIK-SYSTEME GMBH & CO. KG
    Date Cleared
    1996-05-14

    (455 days)

    Product Code
    GCM, EOB, ERA
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    GCM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955120
    Device Name
    HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Date Cleared
    1996-01-26

    (78 days)

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

    GCM

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

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