Note: This device should not be used to do a self-circumcision. Circumcision should always be performed by a trained and skilled healthcare provider.
1.
Stretch the preputial opening if required
8. After
you're sure of the dimensions, apply the plate of the clamp at the level of the corona. |
Shown with light dressing applied. |
Device Marks First 510(k) Clearance for a Significantly Equivalent Surgical Product to be Marketed at Generic Price
GIG HARBOR, Wash.--(BUSINESS WIRE)--Generic Medical Devices, Inc.™ (GMD™), the first company to design, develop, manufacture and supply quality surgical products marketed at generic prices, today announced that the U.S. Food and Drug Administration (FDA) has cleared the GMD 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 will now deliver the benefits of branded devices at costs that help reduce strains on the healthcare system.
“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 (in this case the Gomco circumcision clamp shown above). As a company, we are now able to go to market with widely-used and clinically-proven alternatives to high-priced medical products at costs that are attractive to healthcare organizations and third-party payors alike. The Circumcision Clamp is the first of what we hope will be many generic medical devices brought to market over the next few months.”
The GMD Circumcision 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 GMD Universal Circumcision Clamp is based on the device being substantially equivalent –– 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.
“In addition to opening the door for GMD to market low-cost generic devices for healthcare organizations in the United States, clearance also 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,” continued Kuntz. “The potential humanitarian benefits could be enormous and far reaching.”
About Generic Medical Devices
Generic Medical Devices, Inc.™ is the world’s first designer, developer, manufacturer and supplier of quality medical products marketed at generic prices that allow healthcare providers to meet the standard of care for patients. Recognizing the need for healthcare reform and the ever-increasing burden that America’s aging population is placing on the healthcare system, GMD™ set out to develop lower-priced products with proven outcomes and “better-than” product features. These generic devices, based on products that are becoming a commodity in the marketplace, allow the healthcare system to provide more patients access to innovative and often expensive treatments while helping to stem the tide of rising healthcare costs. Generic Medical Devices, Inc.[TM] (GMD[TM]), announced May 2007 that it has opened for global business with the establishment of its European headquarters in Brussels, Belgium. In addition, J.P. Allar has been named GMD's Vice President, International Sales and Managing Director, GMD Europe, and Daniel Verstappen, R.N. will join GMD as Senior Director, Clinical and Regulatory, GMD Europe.
