Profile: Gyrus ACMI is engaged in medical device business. We offer urology, gynecology, ENT and anesthesiology products. Our urology products include cystourethroscopes, cystonephroscopes, laparoscopy, percutaneous nephroscopes and urodynamics.
The company was founded in 1900, has revenues of USD 50-100 Million, has ~100 employees and is ISO 9000, ISO 9001, ISO 9002, CE certified.
FDA Registration Number: 1519132
• Gastroenterology Electrosurgical Unit (FDA Code: FAR / 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. |
• General & Plastic Surgery Forceps (FDA Code: GEN / 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. |
• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 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. |
• General & Plastic Surgery Surgical Dissector (FDA Code: GDI / 878.4800) |
• General Diagnostic Supplies |
• General Medical Supplies |
• General Purpose Electrosurgical Equipment |
• General Purpose Electrosurgical Unit |
• General Surgery Supplies |
• General Surgical Aids |
• General Surgical Scissors (FDA Code: LRW / 878.4800) |
• Grasping Forceps |
• Guidewires |
• Gynecologic Laparoscope and Accessories (FDA Code: HET / 884.1720) A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts. |
• Hardy Bayonet Forceps |
• Hawkins Blunt Needle |
• Helical Stone Extractors |
• High Resolution Microscope Video Cameras |
• 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. |
• Hysteroscopic Fluid Management Systems |
• Hysteroscopy/Resection Trays |
• Immersable Cystoscopes |
• Inferior Oblique Muscle Forceps |
• Infusion Needle |
• Intracorporeal Lithotripsy Systems |
• Intraocular Foreign-Body Forceps |
• Iris Suturing Forceps |
• Iris Tissue Forceps |
• Irrigation Delivery System |
• Irrigation System |
• Jeweler Type Forceps |
• Kidney Stone Extractors |
• Kleppinger Forceps |
• Kremer Angled Fixation Forceps |
• Kremer Corneal Fixation Forceps |
• Lacrimal System, Bayonette Forceps |
• Laparoscopy Forceps |
• Laparoscopy Kit (FDA Code: FDE / 876.1500) |
• Laparoscopy Scissors |
• Laryngoscopes |
• Left-handed Halsted-Mosquito. Hemostatic Forceps |
• Light Guides |
• Light Sources |
• Light Sources Advanced Light Source |
• Light Sources Alternative Light Source |
• Light Sources Creative Light Source |
• Light Sources Fiber Optic Light Source |
• Light Sources Infrared Light Source |
• Light Sources IR Light Source |
• Light Sources Led Light Source |