Gyrus Group PLC

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Address: Fortran Road, St Mellons, Cardiff CF3 0LT, United Kingdom
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Profile: Gyrus Group PLC is a medical technology company, which focuses on the management of tissue using less traumatic techniques during open and endoscopic surgical procedures. Our products are helpful in gynaecology or laparoscopic, urology, general surgery, otology, head and neck surgery. Our products also help to reduce trauma and complications that accelerate patient healing.

25 Products/Services (Click for related suppliers)

• Active Electrosurgical Electrode (FDA Code: FAS / 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.

• Coaguloop Resection Electrodes

• Commercial Resection Electrodes

• Electrohydraulic Lithotriptor (FDA Code: FFK / 876.4480)

An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.

• Electrosurgical Electrode (FDA Code: JOS / 878.4400)

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• Endoscopic Resection Supplies, Resection Electrodes

• Fiberoptic Illuminator for Endoscope (FDA Code: FFS / 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 Cystoscope and Accessories (FDA Code: FAJ / 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).

• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500)

• 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.

• Laparoscopic Insufflator (FDA Code: HIF / 884.1730)

A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

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

• Nephrostomy Catheter (FDA Code: LJE)

• Resection Electrodes

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

• Resectoscopes (FDA Code: FJL / 876.1500)

• Standard Resection Electrodes

• Surgical Exhaust Apparatus (FDA Code: FYD / 878.5070)

Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.

• Surgical Instrument Tray (FDA Code: FSM / 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.

• Surgical Television Camera with Audio (FDA Code: FWC / 878.4160)

A surgical camera and accessories is a device intended to be used to record operative procedures.

• 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.

• Uterotubal Carbon-Dioxide Insufflator and Accessories (FDA Code: HES / 884.1300)

A uterotubal carbon dioxide insufflator and accessories is a device used to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and fallopian tubes and filling them with carbon dioxide gas.

• Xenon Arc Endoscope Light Source (FDA Code: GCT / 876.1500)