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
|• Alligator Jaw-step Biopsy Forceps|
|• Articulating Tip Laryngoscopes|
|• Balloon Type Catheter (FDA Code: GBA / 878.4200)|
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.
|• Bench Mounted Hopper for X-Ray Film|
|• Biliary & Pancreatic Procedures, Biopsy Forceps|
|• Biliary Stone Retrieval Basket|
|• Biopsy Forceps|
|• Biopsy Forceps Excision|
|• Biopsy Forceps Femoral Approach|
|• Biopsy Forceps with Rotating Shafts|
|• Biopsy Forceps with Two Teeth|
|• Biopsy Forceps, Internal Jugular Approach|
|• Biopsy Forceps, Internal Jugular Approach 7|
|• Blue Rare Earth X-Ray Film|
|• Cervical Biopsy Forceps|
|• Clinical Laboratory Computer|
|• Conventional Laryngoscopes|
|• Cup Biopsy Forceps|
|• Dental X-Ray Film|
|• Diagnostic Incandescent Light Source (FDA Code: FCQ / 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.
|• Diagnostic Ultrasonic Transducer (FDA Code: ITX / 892.1570)|
A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.
|• Disposable Biopsy Forceps|
|• Dissecting Biopsy Forceps|
|• Double Balloon Endoscopy System|
|• Electric Biopsy Forceps (FDA Code: KGE / 876.4300)|
An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.
|• Electrical Power Accessories|
|• Electronic Endoscope|
|• Electrosurgery Control Module|
|• Endoscope Accessories (FDA Code: KOG)|
|• Endoscope Cleaning Brushes & Accessories (FDA Code: MNL / 876.1500)|
|• Endoscope Video Monitor|
|• Endoscopic Access Overtube (FDA Code: FED / 876.1500)|
|• Endoscopic Bite Blocks (FDA Code: MNK / 876.1500)|
|• Endoscopic Cytology Brush (FDA Code: FDX / 876.1500)|
|• Endoscopic Electrosurgical Unit and Accessories (FDA Code: KNS / 876.4300)|
|• Endoscopic Still Camera (FDA Code: FXM / 878.4160)|
A surgical camera and accessories is a device intended to be used to record operative procedures.
|• Endoscopic Television Camera without Audio (FDA Code: FWF / 878.4160)|
|• Endoscopic Video Imaging System/Component (FDA Code: FET / 876.1500)|
|• Endoscopic Wash Bottle|
|• Endoscopy, Flexible Biopsy Forceps|
|• Endoscopy, Hot Biopsy Forceps|
|• Endscopic Magnetic Retriever (FDA Code: FCC / 876.1500)|
|• Enteroscope and Accessories (FDA Code: FDA / 876.1500)|
|• Equipment Cable Adapter|
|• Fiber Optic Blade Laryngoscopes|
|• Fiberoptic Bronchoscopes|
|• Fiberoptic Endoscope (FDA Code: GDB / 876.1500)|
|• Fiberoptic Laryngoscopes|
|• Fiberoptic Photographic Light Source (FDA Code: FCR / 876.1500)|
|• Flexible Biopsy Forceps|