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
• Flexible Endoscopic Grasping Forceps |
• Flexible Gastroscope |
• Flexible Laparoscope |
• Flexible Snare (FDA Code: FDI / 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. |
• Flexible Suction Coagulator Electrode (FDA Code: FEH / 876.4300) |
• Flexible/Rigid Bronchoscope (FDA Code: EOQ / 874.4680) A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier. |
• Flexible/Rigid Choledochoscope and Accessories (FDA Code: FBN / 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. |
• Flexible/Rigid Colonoscope and Accessories (FDA Code: FDF / 876.1500) |
• Flexible/Rigid Duodenoscope and Accessories (FDA Code: FDT / 876.1500) |
• Flexible/Rigid Gastroscope and Accessories (FDA Code: FDS / 876.1500) |
• 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. |
• Flexible/Rigid Sigmoidoscope and Accessories (FDA Code: FAM / 876.1500) |
• Gastrointestinal Tube and Accessories (FDA Code: KNT / 876.5980) A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use). |
• General & Plastic Surgery Colonoscope (FDA Code: FTJ / 876.1500) |
• General & Plastic Surgery Forceps (FDA Code: GEN / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. |
• General & Plastic Surgery Gastroscope (FDA Code: GCK / 876.1500) |
• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500) |
• General & Plastic Surgery Surgical Cannula (FDA Code: GEA / 878.4800) |
• Green Sensitive Rare Earth X-Ray Film |
• Heart Biopsy Forceps |
• Hysteroscope and Accessories (FDA Code: HIH / 884.1690) A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts. |
• Kevorkian-young Biopsy Forceps |
• Laparoscopy Kit (FDA Code: FDE / 876.1500) |
• Laryngoscope/Nasopharyngoscope (FDA Code: EQN / 874.4760) |
• Laryngoscopes |
• Laryngoscopes, Intubation System |
• Line-Powered Electrocautery Unit |
• Miscellaneous Endoscope Bulb Adaptor (FDA Code: FFY / 876.1500) |
• Monitor Support |
• Monopolar Biopsy Forceps |
• Naso-Pharyngo-Laryngoscope |
• Nasoscope |
• Non-Electric Biopsy Forceps (FDA Code: FCL / 876.1075) A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. |
• Non-Rigid Bronchoscope |
• Open Biopsy Forceps |
• Ovarian Biopsy Forceps |
• Panendoscope/Gastroduodenoscope (FDA Code: FAK / 876.1500) |
• Papillotome |
• Polyp Snare |
• Polyp SnareT System for Nasal Polyps |
• Radiographic Image Analysis Computer |
• Radiographic Picture Archiving/Communication System |
• Radiographic X-Ray Film |
• Radiological Image Processing System (FDA Code: LLZ / 892.2050) A picture archiving and communications system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. |
• Rectal Biopsy Forceps |
• Reusable Aspiration and Injection Needle (FDA Code: GDM / 878.4800) |
• Reusable Biopsy Forceps |
• Rotating Uterine Biopsy Forceps |
• Routine Fiberoptic Light Source (FDA Code: FCW / 876.1500) |
• Semi Rigid biopsy forceps |