FDA 510(k) Applications Submitted by Koelis

FDA 510(k) Number Submission Date Device Name Applicant
K100793 03/22/2010 UROSTATION 3D PROSTATE SUITE KOELIS
K160357 02/08/2016 TRINITY KOELIS
K170521 02/22/2017 TRINITY/3D PROSTATE SUITE KOELIS
K171040 04/06/2017 Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range Koelis
K131448 05/20/2013 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION KOELIS
K141334 05/21/2014 REUSABLE GUIDE KOELIS
K180970 04/13/2018 Disposable guides KDNG00 Koelis


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