FDA 510(k)

ShockPulse-SE Lithotripsy System

K-Number: K171024 · 2017-08-21

Decision Date2017-08-21

Product CodeFEO

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ShockPulse-SE Lithotripsy System is the device name listed in this FDA 510(k) record. The listed applicant is Cybersonics, Inc.. It received FDA 510(k) clearance on 2017-08-21 under 510(k) number K171024. The device is classified under product code FEO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ShockPulse-SE Lithotripsy System?

ShockPulse-SE Lithotripsy System is a medical device that received FDA 510(k) clearance on 2017-08-21. The listed applicant is Cybersonics, Inc.. The 510(k) number is K171024.

When did ShockPulse-SE Lithotripsy System receive FDA 510(k) clearance?

ShockPulse-SE Lithotripsy System received FDA 510(k) clearance on 2017-08-21, under 510(k) number K171024.

Who is the listed applicant for ShockPulse-SE Lithotripsy System?

The FDA 510(k) record lists Cybersonics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ShockPulse-SE Lithotripsy System?

The FDA product code for ShockPulse-SE Lithotripsy System is FEO.

Related Devices (Code: FEO)

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.

K230893Swiss LthoClast TrilogyE.M.S Electro Medical Systems S.A K182490Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A K181997Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A K181364Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A K173234Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A

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.