Generic Medical Devices, Inc. (GMD) has received FDA’s 510(k) clearance to distribute and sell its surgical mesh on the American market. The device, with its low price, is thought to be a generic alternative to existing, standard-of-care implantable surgical meshes.
The GMD Universal Surgical Mesh is a Class II, non-active implantable medical device intended to support tissue growth in open or laparoscopic procedures, which are common for hernia repair. Clearance of the GMD Universal Surgical Mesh 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.
“This 510(k) clearance demonstrates GMD’s advancement in the effort to provide FDA approved generic medical devices to a cost-conscious international healthcare community,” added Dr. William Duffell, Jr. Ph.D., Board Member at Generic Medical Devices. “We are excited to continue working with the FDA to introduce new, generic medical devices that meet the highest safety standards while developing devices that ultimately will allow a greater number of patients access to affordable, high-quality and safe healthcare.”
The procedure for patients undergoing laparoscopic or open surgical hernia repair involves the implantation of a surgical mesh over the hernia defect to provide a platform for where tissue ingrowth can occur, healing the defect. The GMD Universal Surgical Mesh will be used for this purpose to repair hernia or other fascial defects that require the addition of a reinforcing or bridging material to achieve the desired surgical outcome.
GMD is the first company to implement the generic model, made successful by the pharmaceutical industry, within the medical device market.
Press release: GENERIC MEDICAL DEVICES RECEIVES FDA 510(K) CLEARANCE FOR UNIVERSAL SURGICAL MESH. Clearance Marks First Generic Surgical Product for Hernia Repair; Expands Company’s Family of Generic Device Offerings …
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