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invendo medical Files 510(K) Notice With FDA for Clearance of the Computer-Assisted Colonoscopy System
Date:3/8/2010

NEW YORK and KISSING, Germany, March 8 /PRNewswire/ -- invendo medical announced today that the company has filed its 510(k) notice submission with the Food and Drug Administration for premarket clearance of the company's new C20™ colonoscopy system including the SC20™ single-use colonoscope. This is the first FDA submission for invendo medical in the United States.

The pivotal clinical trial with the company's single use, advancement-assisted colonoscope in 61 screenees has been completed in December 2009 with encouraging results. The device achieved a 98% cecal intubation rate (60 of 61 subjects), and, while sedation was available to all subjects and doctors upon request, less than 5% of the subjects requested a sedative during the study procedure. There also were no device-related adverse events ob
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