Endoscopic Cameras and Image Processors - India CDSCO Medical Device Registration

Product Information

Stryker endoscopes are used to provide trained and qualified practitioners an internal view or image of patient anatomy for the purposes of examination, diagnosis, and / or therapy. The specific intended use of Stryker endoscopes are made more specific by the device description: • Arthroscopes are indicated for use in arthroscopic procedures performed in the hip, knee, shoulder, wrist ##PLACEHOLDER_0##, temporomandibular joint, ankle, elbow, and foot ##PLACEHOLDER_0##. • Laparoscopes are intended to be used for gynecological and general procedures that clinicians deem appropriate for the patient. Small-diameter Stryker endoscopes ≤ 4 mm in diameter can be used as Sinuscopes. • Sinuscopes are used for visualization during diagnostic and surgical procedures in areas such as the paranasal sinuses. • Sinuscopes are intended to be used for all sinuscopic procedures that clinicians deem appropriate. • Bariatric laparoscopes are intended to be used by surgeons in diagnostic and therapeutic procedures. This includes, but is not limited to, such uses as gallbladder and appendix removal; hernia repair; gastric bypass; laparoscopic Nissen; and examination of the abdominal cavity, appendix, gallbladder, and liver. • Bariatric laparoscopes allow surgeons to perform procedures on morbidly obese segments of their patient population. • Saphenous Vein Harvesting Laparoscopes, in addition to providing an internal view or image of the anatomy of the thoracic or the abdominal cavity, may be used to provide an internal view or image of the saphenous vein. • Cystoscopes are intended for use in general urological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site. They are intended for use in, but not limited to, dilation of the urethra, and cold-slitting of urethral strictures, trans-urethral incision and resection of the prostate and trans-urethral removal of bladder tumors