Cleared Special

K102169 - CYBERWAND LITHOTRIPTER

K102169 is an FDA 510(k) clearance for CYBERWAND LITHOTRIPTER, manufactured by Cybersonics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFK cleared through the Special 510(k) pathway after a 28-day FDA review.

K102169 · Cybersonics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
28d
Days
Class 2
Risk

K102169 is an FDA 510(k) clearance for the CYBERWAND 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 August 30, 2010 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cybersonics, Inc. devices

FDA 510(k) Submission Details - K102169

510(k) Number K102169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2010
Decision Date August 30, 2010
Days to Decision 28 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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
Devices cleared under the same product code (FFK) and FDA review panel - the closest regulatory comparables to K102169.
Swiss LithoClast Trilogy
K191124 · E.M.S Electro Medical Systems S.A · May 2019
AUTOLITH TOUCH
K130368 · Northgate Technologies, Inc. · Nov 2013
SWISS LITHOBREAKER
K123038 · E.M.S Electro Medical Systems S.A · Jan 2013
SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX
K011911 · Richard Wolf Medical Instruments Corp. · Sep 2001
INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)
K011065 · Richard Wolf Medical Instruments Corp. · May 2001
MICROVASIVE LITHOTRIPTOR FLEXPROBE II
K002084 · Boston Scientific Corp · Jul 2000