Cleared Special

K072422 - CYBERWAND STERILE PADS, MODEL: CW-RBPBX (FDA 510(k) Clearance)

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

K072422 · Cybersonics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 130d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Peers - FFK Lithotriptor, Electro-hydraulic

All 60
Devices cleared under the same product code (FFK) and FDA review panel - the closest regulatory comparables to K072422.
Electrohydraulic Lithotriptor (TCS-B3-II)
K242888 · Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Mar 2025
EHL Probe (SCDG-AS)
K243032 · Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Mar 2025
EL27-Compact
K230488 · Walz Elektronik GmbH · Aug 2023
URO-TOUCH 9 French Probe
K202813 · Northgate Technologies, Inc. · Jun 2021