UreTron MultiProbe Lithotripter System
K-Number: K160198 · 2016-02-23
ApplicantMed-Sonics Corp.
Decision Date2016-02-23
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
UreTron MultiProbe Lithotripter System is a medical device manufactured by Med-Sonics Corp.. It received FDA 510(k) clearance on 2016-02-23 under approval number K160198. The device is classified under product code FFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the UreTron MultiProbe Lithotripter System?
UreTron MultiProbe Lithotripter System is a medical device that received FDA 510(k) clearance on 2016-02-23. It is manufactured by Med-Sonics Corp.. The 510(k) number is K160198.
When was UreTron MultiProbe Lithotripter System approved by the FDA?
UreTron MultiProbe Lithotripter System received FDA 510(k) clearance on 2016-02-23, under approval number K160198.
What company makes UreTron MultiProbe Lithotripter System?
UreTron MultiProbe Lithotripter System is manufactured by Med-Sonics Corp..
What is the FDA product code for UreTron MultiProbe Lithotripter System?
The FDA product code for UreTron MultiProbe Lithotripter System is FFK.
Other Devices by Med-Sonics Corp.
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K242888Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.