Profile: Nagashima Medical Instrument Co., Ltd. exports and imports ENT equipment & instruments. Our product line includes cameras for endoscope, camera microscope arm installation, headlights, minute forceps and audiometer.

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• ENT Elevator (FDA Code: KAD / 874.4420)

• ENT Esophageal Bougie (FDA Code: KCD / 874.4420)

• ENT Examining/Treatment Unit (FDA Code: ETF / 874.5300) An ear, nose, and throat examination and treatment unit is an AC-powered device intended to support a patient during an otologic examination while providing specialized features for examination and treatment. The unit consists of a patient chair and table, drawers for equipment, suction and blowing apparatus, and receptacles for connection of specialized lights and examining instruments.

• ENT Forceps (FDA Code: KAE / 874.4420)

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

• ENT Mirror (FDA Code: KAI / 874.4420)

• ENT Nasal Gouge (FDA Code: KAQ / 874.4420)

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

• ENT Probe (FDA Code: KAK / 874.4420)

• ENT Retractor (FDA Code: KAL / 874.4420)

• ENT Surgical Head Support (FDA Code: EPW / 878.4950)

• ENT Syringe (FDA Code: KCP / 874.5220)

• Evoked Response Mechanical Stimulator (FDA Code: GZP / 882.1880) An evoked response mechanical stimulator is a device used to produce a mechanical stimulus or a series of mechanical stimuli for the purpose of measuring a patient's evoked response.

• Evoked Response Photic Stimulator (FDA Code: GWE / 882.1890) An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.

• Examination and Treatment Chair (FDA Code: FRK / 880.6140) A medical chair or table is a device intended for medical purposes that consists of a chair or table without wheels and not electrically powered which, by reason of special shape or attachments, such as food trays or headrests, or special features such as a built-in raising and lowering mechanism or removable arms, is intended for use of blood donors, geriatric patients, or patients undergoing treatment or examination.

• External Functional Neuromuscular Stimulator (FDA Code: GZI / 882.5810) An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.

• Fiberoptic Endoscope (FDA Code: GDB / 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.

• 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.

• 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.

• Forceps Needle Holders

• Gastroenterologic Needle Holder (FDA Code: FHQ / 876.4730) A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

• General & Plastic Surgery Eustachian Catheter (FDA Code: GBY / 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.

• General ENT Supplies

• Hemostats (FDA Code: HRQ / 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.

• Hexagonal Needle Holder

• Hydraulic Surgical Table (FDA Code: FWY / 878.4950)

• Incandescent Endoscopic Lamp (FDA Code: FTI / 876.1500)

• Infant Mouth Gag

• Laryngeal Knife (FDA Code: JZY / 874.4420)

• Laryngostroboscope (FDA Code: EQL / 874.4750) A laryngostroboscope is a device that is intended to allow observation of glottic action during phonation. The device operates by focusing a stroboscopic light through a lens for direct or mirror reflected viewing of glottic action. The light and microphone that amplifies acoustic signals from the glottic area may or may not contact the patient.

• Latex-Free Bite Blocks

• Left Hand Needle Holders

• Low Power Binocular Loupe (FDA Code: HJH / 886.5120) A low-power binocular loupe is a device that consists of two eyepieces, each with a lens or lens system, intended for medical purposes to magnify the appearance of objects.

• Malleus Nipper (FDA Code: JYR / 874.4420)

• Manual Nebulizer Pump (FDA Code: EPN / 874.5220)

• Medical Linear Accelerator (FDA Code: IYE / 892.5050) A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

• Micro Castroviejo Needle Holder with Stopper

• Micro Needle Holder

• Micro Needle Holder Round Handle

• Micro Needle Holders with Flat Handles

• Micro Needle Holders with Lightweight Plastic Handles

• Micro Spring Handle Needle Holder

• Microsurgical Ear Hook (FDA Code: JYL / 874.4420)

• Microsurgical Ear Pick (FDA Code: JYT / 874.4420)

• Microsurgical Instruments (FDA Code: GZX / 882.4525) A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures.

• Microvascular Needle Holders

• Miscellaneous Endoscope Bulb Adaptor (FDA Code: FFY / 876.1500)

• Mouth Gags (FDA Code: KBN / 874.4420)

• Myringotomy Knife (FDA Code: JYP / 874.4420)