Cleared Abbreviated

K120303 - CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K120303 · Cybersonics, Inc. · Gastroenterology & Urology device
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Jun 2012
Decision
125d
Days
Class 2
Risk

K120303 is an FDA 510(k) clearance for the CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM. Classified as Lithotriptor, Electro-hydraulic (product code FFK), Class II - Special Controls.

Submitted by Cybersonics, Inc. (Erie, US). The FDA issued a Cleared decision on June 5, 2012 after a review of 125 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Cybersonics, Inc. devices

Submission Details

510(k) Number K120303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2012
Decision Date June 05, 2012
Days to Decision 125 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 130d · This submission: 125d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FFK Lithotriptor, Electro-hydraulic
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.

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