Aegis Surgical Limited Gets FDA Approval of 510(K) Application
RESEARCH TRIANGLE PARK, January 9, 2015: Aegis Surgical Limited, a medical device company focused on a less invasive surgical access system announces the approval by the Food and Drug Administration of its 510(K) submission for the company’s SupraAA Illuminated Mediastinal Access Port. The Aegis Surgical Limited SuprAA System is an illuminated mediastinoscope access port. The Illuminated Mediastinoscope is a trocar/cannula system used to provide mediastinal surgical access. The disposable device is provided sterile (EO) for single patient use. The device is commercially available in the United States and is also being used clinically in Canada via Health Canada licensing. Aegis Surgical Limited is managed by William Starling and Richard Stack, MD.