UreTron MultiProbe Lithotripter System— 510(k) K160198

Name: FDA 510(k) clearance K160198
Creator: U.S. Food and Drug Administration
Published: 2016-02-23

Substantially Equivalent

Med-Sonics Corp.

FDA 510(k) clearance K160198 for UreTron MultiProbe Lithotripter System, Substantially Equivalent on 2016-02-23. Applicant: Med-Sonics Corp.. Device class: 2.

Clearance details

Applicant: Med-Sonics Corp.
Product code: Code FFK
Device class: Class 2
Regulation: 21 CFR 876.4480
Advisory panel: Gastroenterology, Urology
Date received: 2016-01-28
Decision date: 2016-02-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Erie, PA, US

Download summary PDF View on FDA.gov ↗

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