Generic Circumcision Clamp
Generic Medical Devices, Inc., the first company to design, develop, manufacture and supply quality surgical products marketed at generic prices, recently received FDA clearance for its GMD Universal Circumcision Clamp. The clamp is a Class II medical device intended for use in circumcision procedures generally performed on newborns and less frequently on older males. Clearance of the circumcision clamp is based on the device being substantially equivalent (ie. having the same or equivalent materials, design specifications, technological characteristics, operation, intended use and performance) to pre-amendment devices and a product currently on the market. Additionally, because this type of technology and procedure have a long history of efficacy and clinical use, no additional clinical research was required to establish equivalence.