invendo submits 510(k) application to US FDA
This article was originally published in Clinica
Executive Summary
invendo medical has filed a 510(k) submission with the US FDA seeking market clearance of the company’s C20 colonoscopy system and SC20 single-use colonoscope. The approval application – the firm's first in the US – is based on results from a pivotal trial in 61 subjects, results from which appeared two months ago (www.clinica.co.uk, 5 January 2010). In the trial, lesions were detected in 41% of the subjects, and there were no device-related adverse events. The C20 system is already CE marked in Europe. invendo is based in New York and Kissing, Germany.