Profile: Richard Wolf GmbH develops endoscopes and modular system solutions for all medical fields. We are accredited with ISO9001 and ISO 13485 certification. Our nephroscopy is used to removal of kidney stones.

The company has ~20 employees.

FDA Registration Number: 9611102
US Agent: Mike Loiterman / Richard Wolf Medical Instruments Corp.
Phone: +1-(847)-913-1113  Fax: +1-(847)-913-0924  E-Mail:

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• 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.

• Paper Chart Recorder (FDA Code: DSF / 870.2810) A paper chart recorder is a device used to print on paper, and create a permanent record of the signal from, for example, a physiological amplifier, signal conditioner, or computer.

• Penile Clamp (FDA Code: FHA / 876.5160) A urological clamp for males is a device used to close the urethra of a male to control urinary incontinence or to hold anesthetic or radiography contrast media in the urethra temporarily. It is an external clamp.

• Periodontal Probes

• Pocket Battery Box (FDA Code: FCP / 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.

• 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.

• Probes (FDA Code: HXB / 888.4540)

• Probes (FDA Code: HXB / 888.4540)

• Recording Devices

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

• Resectoscopes (FDA Code: FJL / 876.1500)

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

• Reusable Operating Room Gown

• Reusable Vein Stripper (FDA Code: GAI / 878.4800)

• Rib Rongeurs (FDA Code: HTX / 888.4540)

• Rigid Endoscopes (FDA Code: GCM / 876.1500)

• Rigid Laryngoscope (FDA Code: CCW / 868.5540) A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

• Scalpel Blade (FDA Code: GES / 878.4800)

• Socket Pusher (FDA Code: HXO / 888.4540)

• Soft Ear Speculum (FDA Code: EPY / 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.

• Stabilization and Steering

• Sterile ENT Wire Closure Forceps (FDA Code: JXX / 874.3540) A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by a surgeon to construct ossicular replacements. This generic type of device includes the ear, nose, and throat cutting block; wire crimper, wire bending die; wire closure forceps; piston cutting jib; gelfoamTMpunch; wire cutting scissors; and ossicular finger vise.

• Sterile ENT Wire Cutting Scissors (FDA Code: JYA / 874.3540)

• Sterile Filter Basket System

• Sterile Specimen Container (FDA Code: FMH / 864.3250) A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.

• Sterilization Wrap Containers (FDA Code: KCT / 880.6850) A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

• Suction Catheter and Tip (FDA Code: JOL / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

• Surgical Camera and Accessories (FDA Code: KQM / 878.4160) A surgical camera and accessories is a device intended to be used to record operative procedures.

• Surgical Curette (FDA Code: FZS / 878.4800)

• Surgical Hammer (FDA Code: FZY / 878.4800)

• Surgical Headband Light (FDA Code: FSR / 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.

• Surgical Instrument Tray (FDA Code: FSM / 878.4800)

• Surgical Metal Tongue Depressor (FDA Code: KBL / 874.4420)

• Surgical Microscopes (FDA Code: EPT / 878.4700) A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.

• Surgical Orthopedic Scissors (FDA Code: HRR / 888.4540)

• Surgical Retractor (FDA Code: GAD / 878.4800)

• Surgical Retractor Systems (FDA Code: GAD / 878.4800)

• Surgical Snare (FDA Code: GAE / 878.4800)

• Surgical Urethral Catheter (FDA Code: GBM / 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).

• Table Operating Room Accessories (FDA Code: FWZ / 878.4950) A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

• Tonsil Snares (FDA Code: KBZ / 874.4420)

• Tonsil Suction Tube (FDA Code: KCB / 874.4420)

• Tonsillectome (FDA Code: KCA / 874.4420)

• Tracheal Trocar (FDA Code: KCI / 874.4420)

• Transcervical Endoscope & Accessories (FDA Code: HEZ / 884.1660) A transcervical endoscope is a device designed to permit direct viewing of the fetus and amniotic sac by means of an open tube introduced into the uterus through the cervix. The device may be used to visualize the fetus or amniotic fluid and to sample fetal blood or amniotic fluid. This generic type of device may include obturators, instruments used through an operating channel, light sources and cables, and component parts.

• Tube Introduction Forceps (FDA Code: BWB / 868.5780) Tube introduction forceps (e.g., Magill forceps) are a right-angled device used to grasp a tracheal tube and place it in a patient's trachea.

• Urethral Catheters (FDA Code: GBM / 876.5130)

• Urethrometer (FDA Code: FBR / 876.5520) A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower.

• Urethroscope (FDA Code: FGC / 876.1500)

• Urethrotome (FDA Code: EZO / 876.4770) A urethrotome is a device that is inserted into the urethra and used to cut urethral strictures and enlarge the urethra. It is a metal instrument equipped with a dorsal-fin cutting blade which can be elevated from its sheath. Some urethrotomes incorporate an optical channel for visual control.