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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Med-Sonics Corp.. It received FDA 510(k) clearance on 2016-02-23 under 510(k) 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. The listed applicant is Med-Sonics Corp.. The 510(k) number is K160198.

When did UreTron MultiProbe Lithotripter System receive FDA 510(k) clearance?

UreTron MultiProbe Lithotripter System received FDA 510(k) clearance on 2016-02-23, under 510(k) number K160198.

Who is the listed applicant for UreTron MultiProbe Lithotripter System?

The FDA 510(k) record lists Med-Sonics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UreTron MultiProbe Lithotripter System?

The FDA product code for UreTron MultiProbe Lithotripter System is FFK.

Other records listing Med-Sonics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162119UreTron PF Series Probe

Related Devices (Code: FFK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.K242888Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.K230488EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbHK202813URO-TOUCH 9 French ProbeNorthgate Technologies, Inc.K191124Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.AK162119UreTron PF Series ProbeMed-Sonics Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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