Profile: Xion medical GmbH offers complete endoscopy systems for various applications. The product range includes rigid & flexible endoscopes, camera systems, light sources, suction & irrigation pumps, insufflators and other equipment for the application fields of arthroscopy, ENT, laparoscopy & gynaecology. Our ENT video endoscopy systems provide precise technologies for optimal diagnostics and therapy. We offer a wide range of otoscopes, endoscopes for the nose and sinuses, as well as laryngo-pharyngoscopes. Our ENT endoscopes are robust, have a long lifetime and convince with optimal handling. Large, bright and sharp images are the result of the optical systems. We develop and manufacture endoscopes for ENT with diameters of 2.7 mm & 4.0 mm. These are applied particularly in the ear, nose and sinuses. It features high detail fidelity for reliable diagnosis, high depth of focus even in marginal areas, evenly illuminated operation field, compatible to existing systems through adapter programs, ocular housing and optic sheath completely made of stainless steel & fully autoclavable. Our laparoscopy workplaces for the operating room features functionality and optimal handling. They can be integrated into the clinics' networks via DICOM. The modular design of the laparoscopic instruments make it easy to choose from a variety of jaws, sheaths and handles & put together the instrument for the particular operation. The instrument sheaths are rotatable by 360°.
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• Fiberoptic Light Source & Carrier (FDA Code: EQH / 874.4350) An ear, nose, and throat fiberoptic light source and carrier is an AC-powered device that generates and transmits light through glass of plastic fibers and that is intended to provide illumination at the tip of an ear, nose, or throat endoscope. Endoscopic devices which utilize fiberoptic light sources and carriers include the bronchoscope, esophagoscope, laryngoscope, mediastinoscope, laryngeal-bronchial telescope, and nasopharyngoscope. |
• Flexible/Rigid Nasopharyngoscope (FDA Code: EOB / 874.4760) A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier. |
• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. |
• Laryngostroboscope (FDA Code: EQL / 874.4750) A laryngostroboscope is a device that is intended to allow observation of glottic action during phonation. The device operates by focusing a stroboscopic light through a lens for direct or mirror reflected viewing of glottic action. The light and microphone that amplifies acoustic signals from the glottic area may or may not contact the patient. |
• Non Rigid Laryngoscope (FDA Code: CAL / 868.5530) A flexible laryngoscope is a fiberoptic device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube. |
• Rigid Laryngoscope (FDA Code: CCW / 868.5540) A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube. |
• Surgical Cine Camera With Audio (FDA Code: FWI / 878.4160) A surgical camera and accessories is a device intended to be used to record operative procedures. |