Profile: Karl Storz GmbH & Co. KG specializes in the production and sale of medical instruments & devices. We offer a range of endoscopic equipment for human & veterinary medicine and for industrial applications. The instruments developed by us permit a whole range of endoscopic, minimally invasive operations, such as support immersion endoscopy, cavity endoscopy, endoscopic treatment of disorders of the salivary duct, arthroscopy of the temperomandibular joint and endoscopically assisted procedures for treating comminuted fractures of the zygomatic arch, the zygomatic process and the condylar process. Our otorhinolaryngology branch of medicine comprises rigid endoscopes spanning the entire spectrum of lengths, diameters and directions of view, flexible fiberscopes & close on 6,000 different instruments. We also offer an extensive product range for skull base surgery, pituitary gland surgery and otoneurosurgery, which includes a large number of flexible & rigid endoscopes as well as instruments for advanced operating techniques in this field. From basic equipment for the ENT practice through complete sets of endoscopic and surgical instruments up to the high-technology system for video-assisted endoscopy & autofluorescence, we provide an entire range of endoscopes & instruments.

The company has ~2000 employees and is ISO 9000, ISO 9001, ISO 9002, ISO 9003, CE certified.

FDA Registration Number: 9614434
US Agent: Susie S. Chen / Karl Storz Endoscopy-america, Inc.
Phone: +1-(424)-218-8201  Fax: +1-(424)-218-8519  E-Mail:

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• Neurology Monitors

• Non Rigid Bronchoscope Biopsy Forceps (FDA Code: BWH / 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.

• Non Rigid Bronchoscope for Foreign Body Removal (FDA Code: JEI / 874.4680)

• Non Rigid Laryngoscope (FDA Code: CAL / 868.5530) A flexible laryngoscope is a fiberoptic device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

• Non-Disposable Suprapubic Trocar and Cannula (FDA Code: FBM / 876.5090) A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.

• 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-Electrical Rigid Sigmoidoscope (FDA Code: KDM / 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.

• Non-Powered Portable Single Patient Suction Apparatus (FDA Code: GCY / 878.4680) A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.

• Non-Powered Surgical Instrument (FDA Code: HAO / 882.4535) A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc.

• Non-Rigid Bronchoscope

• Non-Ventilating Rigid Bronchoscope

• Nose And Throat Ear Bur (FDA Code: EQJ / 874.4140) An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.

• Observerscope

• Open Biopsy Forceps

• Operating Room Equipment, Cameras

• Ophthalmic Retractor (FDA Code: HNI / 886.4350) A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

• Ophthalmology Needle Holders

• Ophthalmology, Surgical Instrument Trays

• Orthopedic Cutting Instrument (FDA Code: HTZ / 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.

• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540) An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

• Otoscopes (FDA Code: ERA / 874.4770) An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system.

• Oval Biopsy Punch Forceps

• Ovarian Biopsy Forceps

• Partial Ossicular Replacement Prosthesis (FDA Code: ETB / 874.3450) A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.

• Pediatric Cystoscopes

• Pediatric Tube Needle Holder Adapter

• Percutaneous Nephroscopes

• Peritoneoscope (FDA Code: GCG / 876.1500)

• Pharyngoscope

• Pinard Fetoscope

• Pneumatic Powered Orthopedic Surgical Instrument & Accessory (FDA Code: HSZ / 878.4820)

• Pneumoperitoneum Needle (FDA Code: FHO / 876.1500)

• Polyp Snare

• Polyp SnareT System for Nasal Polyps

• Powered Surgical Laser Instrument (FDA Code: GEX / 878.4810) (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.

• Pressure Tubing and Accessories (FDA Code: BYX / 868.5860) Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases.

• Probes (FDA Code: HXB / 888.4540)

• Proctoscopes (FDA Code: GCF / 876.1500)

• Protective Barrier Cover (FDA Code: MMP / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

• PVC Thoracic Trocars

• Radiological Digital Image Communication System (FDA Code: LMD / 892.2020) A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol.

• Radiological Digital Image Storage Device (FDA Code: LMB / 892.2010) A medical image storage device is a device that provides electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory.

• 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

• Resectoscope Working Element (FDA Code: FDC / 876.1500)

• Resectoscopes (FDA Code: FJL / 876.1500)

• Retractors

• Retractors

• Reusable Aspiration and Injection Needle (FDA Code: GDM / 878.4800)

• Reusable Biopsy Forceps