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
• Light Sources Microscope Light Source |
• Light Sources Ultra Violet Light Source |
• Light Sources UV Light Source |
• Light Sources White Light Source |
• Light Sources Xenon Light Source |
• Lithotripsy Systems |
• Long Cilia Forceps |
• Long Handle Curettes |
• Manual Gastro-Urology Surgical Instrument (FDA Code: KOA / 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. |
• Micro Axial Curettes |
• Micro Suturing Forceps |
• Micro Utility Forceps with Spring-lock |
• Microdissection Needle Electrodes |
• Micron Adjustable Titanium Implant Systems |
• Microsurgical Bipolar Forceps |
• Microsurgical Instruments (FDA Code: GZX / 882.4525) A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures. |
• Microwave Thermotherapy (TUMT) Systems |
• Microwave Treatments, Cooled Thermotherapy |
• Mini Cystoscopes |
• Miniature Light Guides |
• Minimally Invasive BPH Therapies |
• Minimally Invasive BPH Treatment Device |
• Miscellaneous Endoscope Bulb Adaptor (FDA Code: FFY / 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. |
• modified bayonet Forceps |
• Modified Watchmaker's Forceps |
• Multi-Flex Open Tip Urethral Stent Kit |
• Multi-Length Urethral Stents |
• Multi-Use Electrocauterization Probe |
• Nasal Cutting Forceps |
• Needle Electrode (FDA Code: GXZ / 882.1350) A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals. |
• Nephroscopes |
• Nephrostomy Tract Dilation Sets |
• Non-Cantilevered Ringed Forceps |
• Non-Coherent Light Sources |
• Non-Coherent Light Sources For Confocal Microscopy |
• 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-Invasive Tubing (FDA Code: GAZ / 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). |
• Nonstick Needle Electrode |
• Obstetrical Forceps (FDA Code: HDA / 884.4400) An obstetric forceps is a device consisting of two blades, with handles, designed to grasp and apply traction to the fetal head in the birth passage and facilitate delivery. |
• Obturators |
• Open Biopsy Forceps |
• Open Tip Urethral Stents |
• Operating Room Equipment, Cameras |
• Operative Hysteroscope Sheath and Integral Bridge |
• Ophthalmic Epilation Forceps |
• Orthopedic Forceps |
• Oval Cupped Intraocular Forceps |
• Ovarian Biopsy Forceps |
• Palatal Obturators |
• Pediatric Cystoscopes |