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GIMMI ALPHA® Gastro-Urology and Laparoscopic Endoscopes, Endoscopic Accessories and GIMMI devices for minimally invasive gastrointestinal (GI), genitourinary (GU), and laparoscopic diagnostic and/or therapeutic indications are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/urologic and minimally invasive procedures.

GIMMI ALPHA Endoscopes are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use. Laparoscopic and urological-gastroenterologic and related accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. Needle holders and other Class I devices included in the endoscopic catalogs may be onepiece. The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures (grasping, cutting, dissecting, coagulating and suturing). Minimally Invasive Gl and GU Devices are design specific for short term use in diagnostic and/or therapeutic procedures

Resectoscope and Laser Resectoscope Working Elements are intended to be used in urological procedures to endoscopically remove, cut, coagulate, and/or transect tissue in the bladder, prostate, and/or urethra. The surgeon performs the examination through the urethra. The working elements are devices that house and control the various electrodes and lasers used to remove, cut, coagulate, and transect tissue. The doctor controls the back and forth movement of the electrode using finger controls. The working elements also house a cystoscope for visualization. The high frequency cable transmits electrical current. Albarran deflectors are intended for use in urological procedures to control the flexible instrumentation that is passed through the COMEG cystoscope sheaths. Urethrotomes are intended to be used in urological procedures to endoscopically cut and or transect tissue(strictures) in the urethra. The surgeon performs this function through the urethra and will visually (cystoscope) find the location of the stricture in the urethra. Once the stricture is located a urethrotome knife will be extended an the entire urethrotome will be extracted cutting the affected area. Electrodes are intended to be used endoscopically im conjunction with COMEG resectoscopes, urethrotomes, or cystoscope sheaths. The purpose of the electrodes is for cutting, tissue removal, tissue vaporization, coagulation, and/or transection of tissue. Electrodes are connected to either a resectoscope working element or a high frequency cable. The electrodes are reusable.

The COMEG devices that we intend to market include the following endoscopic electrosurgical instruments and accessories: resectoscope and laser-resectoscope working elements; Albarran deflectors; urethrotomes (urethrotome bridges, obturators, and knives); high frequency cable; and, electrodes. A "Quick-Connection" feature is used to attach the device to the sheath or working element. Endoscopic electrosurgical instruments and accessories are described in endoscope and accessories 21 CFR 8876.1500, urethrotomes are described in 21 CFR §876.4770, and endoscope ESU unit and accessories are described in 21 CFR §876.4300. The Resectoscope and Laser Resectoscope Working Elements are intended to be used in urological procedures to endoscopically remove, cut, coagulate, and/or transect tissue in the bladder, prostate, and/or urethra. The surgeon performs the examination through the urethra. The working elements are devices that house and control the various electrodes and lasers used to remove, cut, coagulate, and transect tissue. The doctor controls the back and forth movement of the electrode using finger controls. The working elements also house a cystoscope for visualization. The high frequency cable transmits electrical current. These devices are composed of stainless steel chrome plated, plastic, and brass chrome plated. The high frequency cable is composed of silicone. Albarran deflectors are intended for use in urological procedures to control the flexible instrumentation that is passed through the COMEG cystoscope sheaths. These devices are composed of stainless steel chrome plated and brass chrome plated. The intended use for the urethrotomes is in urological procedures to endoscopically cut and/or transect tissue (strictures) in the urethra. The surgeon performs this function through the urethra and will visually (cystoscope) find the location of the stricture in the urethra. Once the stricture is located a urethrotome will be extracted, cutting the affected area. These devices are composed of stainless steel chrome plated, plastic, and brass chrome plated. The complete working unit is comprised of each of the models below plus a cystoscope. The electrodes are intended to be used endoscopically in conjunction with COMEG resectoscopes, urethrotomes, or cystoscope sheaths. The purpose of the electrodes is for cutting, tissue removal, tissue vaporization, coagulation, and/or transection of tissue. Electrodes are connected to either a resectoscope working element or a high frequency cable. The electrodes are reusable. These electrodes are composed of stainless steel, teflon, silicone, ultem (black plastic), tungsten, and silver.