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FDA 510(k)

Swiss LithoClast Trilogy

K-Number: K191124 · 2019-05-29

ApplicantE.M.S Electro Medical Systems S.A
Decision Date2019-05-29
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Swiss LithoClast Trilogy is a medical device manufactured by E.M.S Electro Medical Systems S.A. It received FDA 510(k) clearance on 2019-05-29 under approval number K191124. 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 Swiss LithoClast Trilogy?

Swiss LithoClast Trilogy is a medical device that received FDA 510(k) clearance on 2019-05-29. It is manufactured by E.M.S Electro Medical Systems S.A. The 510(k) number is K191124.

When was Swiss LithoClast Trilogy approved by the FDA?

Swiss LithoClast Trilogy received FDA 510(k) clearance on 2019-05-29, under approval number K191124.

What company makes Swiss LithoClast Trilogy?

Swiss LithoClast Trilogy is manufactured by E.M.S Electro Medical Systems S.A.

What is the FDA product code for Swiss LithoClast Trilogy?

The FDA product code for Swiss LithoClast Trilogy is FFK.

Other Devices by E.M.S Electro Medical Systems S.A

K151912AIR-FLOW handy 3.0 PLUS K171174PERIO-FLOW nozzle K171189AIR-FLOW PLUS Prophylaxis powder K182490Swiss LithoClast Trilogy K181997Swiss LithoClast Trilogy K181364Swiss LithoClast Trilogy

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Related Devices (Code: FFK)

K162119UreTron PF Series ProbeMed-Sonics Corp. K160198UreTron MultiProbe Lithotripter SystemMed-Sonics Corp. K202813URO-TOUCH 9 French ProbeNorthgate Technologies, Inc. K230488EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbH K242888Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

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.

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