Cleared Special

UreTron MultiProbe Lithotripter System

K160198 · Med-Sonics Corp. · Gastroenterology & Urology

Feb 2016

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K160198 is an FDA 510(k) clearance for the UreTron MultiProbe Lithotripter System, a Lithotriptor, Electro-hydraulic (Class II — Special Controls, product code FFK), submitted by Med-Sonics Corp. (Erie, US). The FDA issued a Cleared decision on February 23, 2016, 26 days after receiving the submission on January 28, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4480.

Submission Details

510(k) Number	K160198 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 28, 2016
Decision Date	February 23, 2016
Days to Decision	26 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement