Profile: Olympus Imaging Corporation specializes in medical endoscopes and surgical products,artificial bone replacement material and dental products. We also deal with microscopes and the medical information systems program. The Evis Lucera upper alimentary canal general-purpose video scope corresponds to nose oral insertion as one of inspection expedient of the upper alimentary canal. Its diameter actualizes high picture quality conversion of the same level as the 9.0 mm diameter which is widely used.

FDA Registration Number: 8010047
US Agent: Laura Storms / Olympus America, Inc.
Phone: +1-(484)-896-5688  Fax: +1-(484)-896-7128  E-Mail:

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• Endoscopic Obturator (FDA Code: FEC / 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.

• Endoscopic Rigid Telescope (FDA Code: FBP / 876.1500)

• Endoscopic Teaching Attachment (FDA Code: FEA / 876.1500)

• Endoscopic Television Camera without Audio (FDA Code: FWF / 878.4160) A surgical camera and accessories is a device intended to be used to record operative procedures.

• Endoscopic Video Imaging System/Component (FDA Code: FET / 876.1500)

• ENT Applicator (FDA Code: KCJ / 874.5220) An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.

• ENT Drug Applicator (FDA Code: LRD / 874.5220)

• ENT Elevator (FDA Code: KAD / 874.4420)

• ENT Forceps (FDA Code: KAE / 874.4420)

• ENT Irrigation Syringe (FDA Code: KCP / 874.5220)

• ENT Knife (FDA Code: KTG / 874.4420)

• ENT Manual Surgical Instrument (FDA Code: LRC / 874.4420)

• ENT Mirror (FDA Code: KAI / 874.4420)

• ENT Nerve Stimulator (FDA Code: ETN / 874.1820) A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

• ENT Powder Blower (FDA Code: KCL / 874.5220)

• ENT Probe (FDA Code: KAK / 874.4420)

• ENT Punch (FDA Code: KTF / 874.4420)

• ENT Retractor (FDA Code: KAL / 874.4420)

• ENT Speculum Holder (FDA Code: KAG / 878.1800) A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.

• ENT Surgical Tray (FDA Code: MMO / 874.4420)

• ENT Synthetic Polyamide Polymer (FDA Code: KHJ / 874.3620) Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.

• ENT Syringe (FDA Code: KCP / 874.5220)

• ENT Trocar (FDA Code: KTE / 874.4420)

• Enteroscope and Accessories (FDA Code: FDA / 876.1500)

• Epistaxis Balloon (FDA Code: EMX / 874.4100) An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.

• Esophageal Ligator (FDA Code: MND / 876.4400) A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.

• Fiberoptic Endoscope (FDA Code: GDB / 876.1500)

• Fiberoptic Focusing Headlight (FDA Code: FCT / 886.4335) An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.

• 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.

• Fiberoptic Surgical Light (FDA Code: FST / 878.4580) A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

• Flexible Endoscope Accessory Hanger

• Flexible Endoscope Repair Parts - Biopsy Channels

• Flexible Endoscope Repair Parts - Insertion Tubes

• Flexible Endoscopes (FDA Code: GCQ / 876.1500)

• 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 Stone Dislodger (FDA Code: FGO / 876.4680) A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.

• 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)

• Flexible/Rigid Colonoscope and Accessories (FDA Code: FDF / 876.1500)

• Flexible/Rigid Cystoscope and Accessories (FDA Code: FAJ / 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)

• Flexible/Rigid Ureteroscope and Accessories (FDA Code: FGB / 876.1500)

• Gastro-Urology Catheter & Accessories (FDA Code: KNY / 876.5130) A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

• Gastro-Urology Endoscopic Injection Needle (FDA Code: FBK / 876.1500)

• Gastro-Urology Evacuator (FDA Code: KQT / 876.4370) A gastroenterology-urology evacuator is a device used to remove debris and fluids during gastroenterological and urological procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator system, manually powered bladder evacuator, and the AC-powered vacuum pump.

• Gastro-Urology Ureteral Catheter (FDA Code: EYB / 876.5130)