FDA CLEARS MARKETING OF GENERIC CIRCUMCISION CLAMP

Generic Medical Devices (GMD) announced that the FDA has cleared the firm's Universal Circumcision Clamp for market.

"This marks the company's first 510(k) clearance by the FDA for a medical device that will be sold as a generic alternative to existing, standard-of-care surgical products," GMD said Jan. 22.

GMD's circumcision clamp is a Class II device meant for use in procedures generally performed on newborns, the firm said.

Clearance for the device "gives us the chance to begin exploring opportunities with organizations in Third World nations where there is an immediate need for proven and affordable devices that could help stem infection rates for such diseases as HIV," GMD President and CEO Richard Kuntz said.