Cleared Abbreviated

K052135 - CYBERSONICS CYBERWAND DUAL PROBE LITHOT...

K052135 is an FDA 510(k) clearance for CYBERSONICS CYBERWAND DUAL PROBE LITHOT..., manufactured by Cybersonics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFK cleared through the Abbreviated 510(k) pathway after a 137-day FDA review.

K052135 · Cybersonics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
137d
Days
Class 2
Risk

K052135 is an FDA 510(k) clearance for the CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER. 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 December 20, 2005 after a review of 137 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

FDA 510(k) Submission Details - K052135

510(k) Number K052135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2005
Decision Date December 20, 2005
Days to Decision 137 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
7d slower than avg
Panel avg: 130d · This submission: 137d
Pathway characteristics
Standards-based clearance path.

FFK Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FFK Lithotriptor, Electro-hydraulic

All 31
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