Cleared Traditional

K171024 - ShockPulse-SE Lithotripsy System

K171024 is an FDA 510(k) clearance for ShockPulse-SE Lithotripsy System, manufactured by Cybersonics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FEO cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K171024 · Cybersonics, Inc. · Gastroenterology & Urology device
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Aug 2017
Decision
138d
Days
Class 2
Risk

K171024 is an FDA 510(k) clearance for the ShockPulse-SE Lithotripsy System. Classified as Lithotriptor, Ultrasonic (product code FEO), Class II - Special Controls.

Submitted by Cybersonics, Inc. (Erie, US). The FDA issued a Cleared decision on August 21, 2017 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4480 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cybersonics, Inc. devices

FDA 510(k) Submission Details - K171024

510(k) Number K171024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2017
Decision Date August 21, 2017
Days to Decision 138 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 130d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FEO Device Classification - Class 2, Special Controls

Product Code FEO Lithotriptor, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4480
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FEO Lithotriptor, Ultrasonic

All 10
Devices cleared under the same product code (FEO) and FDA review panel - the closest regulatory comparables to K171024.
Swiss LithoClast Trilogy
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Swiss LithoClast Trilogy
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KSEA CALCUSON
K973251 · KARL STORZ Endoscopy-America, Inc. · Jun 1998
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K920235 · Richard Wolf Medical Instruments Corp. · Dec 1992
OLYMPUS LUS ULTRASONIC LITHOTRIPTER
K873367 · Olympus Corp. · Nov 1987