A Medical Device Daily

Generic Medical Devices (GMD; Gig Harbor, Washington) reported Monday that it has received FDA 510(k) clearance for its universal circumcision clamp. This marks the company’s first 510(k) for a medical device that will be sold as a generic alternative to existing surgical products.

GMD last month unveiled its plan to follow the pharma model of manufacturing off-patent medical device as generics at “generic prices” (Medical Device Daily, Dec. 12, 2006), saying it is the first company to use this model in the device arena.

It says that the devices it chooses to make “all have existing 510(k) classification, reimbursement by Medicare and third-party payors, established product safety, efficacy and outcomes, and a trained surgeon/physician base.”

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 is based on the device substantial equivalence to pre-amendment devices and a product currently on the market.

Richard Kuntz, president/CEO of GMD, said, “The FDA’s review and clearance of the GMD universal circumcision clamp is evidence that generic devices are as safe and effective as the original, brand name products. . . . The Circumcision Clamp is the first of what we hope will be many generic medical devices brought to market over the next few months.”