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FDA 510(k)

ShockPulse-SE Lithotripsy System

K-Number: K171024 · 2017-08-21

ApplicantCybersonics, Inc.
Decision Date2017-08-21
Product CodeFEO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ShockPulse-SE Lithotripsy System is a medical device manufactured by Cybersonics, Inc.. It received FDA 510(k) clearance on 2017-08-21 under approval 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. It is manufactured by Cybersonics, Inc.. The 510(k) number is K171024.

When was ShockPulse-SE Lithotripsy System approved by the FDA?

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

What company makes ShockPulse-SE Lithotripsy System?

ShockPulse-SE Lithotripsy System is manufactured by Cybersonics, Inc..

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

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

Related Clinical Trials

NCT06662500 FORWARD CAD IDE Study RECRUITING NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING NCT07510438 AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease RECRUITING NCT06149650 Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study RECRUITING NCT07575568 Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen NOT_YET_RECRUITING NCT07512128 Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral Stenting (SKYWARD Trans-Femoral IDE [Investigational Device Exemption] Study) NOT_YET_RECRUITING

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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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