Generic Surgical Mesh Hits Market

Generic Medical Devices, of Gig Harbor, WA, today received its second 501(k) clearance, for its GMD Universal Surgical Mesh product. The company is the first in the medical device field to implement a generic model similar to the one that has posed great threat to branded pharmaceutical firms.

The GMD Universal Surgical Mesh is a Class II, non-active implantable device intended to support tissue growth in open or laparoscopic procedures, which are common for hernia repair. Clearance of the device is based on it 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.

Several surgical device companies make mesh, including Ethicon (a Johnson & Johnson company), which manufactures Proceed, and Hudson, NH-based Atrium Medical Corporation, maker of ProLite Mesh.

“With more than one million hernia operations performed in the United States in the last year alone, the ability to offer healthcare organizations a low-cost surgical mesh for each procedure will create immediate fiscal savings that can be reinvested to provide more patients with needed surgical procedures and support new device innovations,” CEO Richard Kuntz said in a statement.

Generic Medical Device’s first 501(k) clearance came in January 2007, for its GMD Universal Circumcision Clamp, used for circumcision procedures.

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