Profile: Fujinon, Inc. supplies endoscopic equipment. We offer the latest in endoscopic solutions for outpatient facilities, hospitals and teaching institutions. Our most advanced G-5™ endoscopes are now available across our two-tiered product range, including the 2200 and 4400 systems. Our latest product addition is the EPX-4400, a fully digital system that takes video endoscopy beyond the capabilities of its predecessors.
The company is ISO 9000 certified.
FDA Registration Number: 2431293
• Standard Oval Biopsy Forceps |
• Surgical Camera and Accessories (FDA Code: KQM / 878.4160) A surgical camera and accessories is a device intended to be used to record operative procedures. |
• Surgical Television Camera without Audio (FDA Code: FWB / 878.4160) |
• Thoracoscopes |
• Tracheal Tube Cleaning Brushes (FDA Code: EPE / 868.5795) A tracheal tube cleaning brush is a device consisting of a brush with plastic bristles intended to clean tracheal cannula devices after their removal from patients. |
• Tubing And Tubing/Filter Fits (FDA Code: NVT / 884.1700) A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope. |
• Ultrasonic Puls-Echo Scanner (FDA Code: IYO / 892.1560) An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. |
• Ultrasonic Pulsed Doppler Imaging System (FDA Code: IYN / 892.1550) An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. |
• Unipolar Laparoscopic Coagulator (FDA Code: HFG / 884.4160) A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation. |
• Ureteroscopic Biopsy Forceps |
• Uterine Biopsy Forceps |
• Video Equipment Cart |
• Videotape/Videodisc Recorder |
• X-Ray Film |
• X-Ray Film Block Shelter |
• X-Ray Film Cabinet |
• X-Ray Film Cassette Repairs |
• X-ray Film Digitizers |
• X-Ray Film Duplicators |
• X-Ray Film Envelopes |
• X-Ray Film Flexible Blockers |
• X-Ray Film Holder |
• X-Ray Film Keeping Self |
• X-Ray Film Loading & Unloading Table |
• X-Ray Film Marking Pencils |
• X-Ray Film Processors |
• X-Ray Film Scanners |
• X-Ray Film Scanning Software |
• X-Ray Film Storage Bin |
• X-Ray Film Storage Box |
• X-Ray Film Storage Cabinet |
• X-Ray Film Transport Caddies |
• X-Ray Film Viewer |
• Xenon Arc Endoscope Light Source (FDA Code: GCT / 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. |