Cleared Traditional

K142428 - Shock Pulse-SE Lithotripsy System CYBERWAND II (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K142428 · Cybersonics, Inc. · Gastroenterology & Urology device
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Nov 2014
Decision
76d
Days
Class 2
Risk

K142428 is an FDA 510(k) clearance for the Shock Pulse-SE Lithotripsy System CYBERWAND II. Classified as Lithotriptor, Ultrasonic (product code FEO), Class II - Special Controls.

Submitted by Cybersonics, Inc. (Erie, US). The FDA issued a Cleared decision on November 13, 2014 after a review of 76 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cybersonics, Inc. devices

Submission Details

510(k) Number K142428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2014
Decision Date November 13, 2014
Days to Decision 76 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
54d faster than avg
Panel avg: 130d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.