Cleared Special

K072422 - CYBERWAND STERILE PADS, MODEL: CW-RBPBX

K072422 is an FDA 510(k) clearance for CYBERWAND STERILE PADS, 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 57-day FDA review.

K072422 · Cybersonics, Inc. · Gastroenterology & Urology device
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Oct 2007
Decision
57d
Days
Class 2
Risk

K072422 is an FDA 510(k) clearance for the CYBERWAND STERILE PADS, MODEL: CW-RBPBX. 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 October 24, 2007 after a review of 57 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 - K072422

510(k) Number K072422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2007
Decision Date October 24, 2007
Days to Decision 57 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 131d · This submission: 57d
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 45
Devices cleared under the same product code (FFK) and FDA review panel - the closest regulatory comparables to K072422.
URETRON MODEL URT
K111058 · Med-Sonics Corp. · Mar 2012
CYBERWAND LITHOTRIPTER
K102169 · Cybersonics, Inc. · Aug 2010
VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR
K092033 · Elmed USA · Apr 2010
LMA STONEBREAKER DEVICE
K062475 · The Laryngeal Mask Co., Ltd. · May 2007
CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER
K052135 · Cybersonics, Inc. · Dec 2005
SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX
K011911 · Richard Wolf Medical Instruments Corp. · Sep 2001