Profile: Mauna Kea Technologies specializes in Cellvizio® probe-based confocal laser endomicroscopy systems for GI endoscopy, and interventional pulmonology. Cellvizio® technology platform enables real-time dynamic observation of tissues at the microscopic level which is designed for minimally-invasive and streamlined interventions. Cellvizio lung is a unique, versatile & complete solution for smooth dynamic microscopic imaging during endoscopy. Cellvizio® LAB is easy to use solution for in vivo, in situ microscopic imaging of any location in the brain which is watching neurons at work at any location in the brain with cellular resolution.
FDA Registration Number: 3004542960
US Agent: Kristine Kelly / Mauna Kea Technologies Inc
Phone: +1-(617)-657-1550 Fax: +1-(408)-729-1889 E-Mail:
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• 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. |