Cleared Special

K132795 - CYBERWAND STERILE PROBE SET (FDA 510(k) Clearance)

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

K132795 · Cybersonics, Inc. · Gastroenterology & Urology device
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Nov 2013
Decision
81d
Days
Class 2
Risk

K132795 is an FDA 510(k) clearance for the CYBERWAND STERILE PROBE SET. 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 November 26, 2013 after a review of 81 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 K132795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2013
Decision Date November 26, 2013
Days to Decision 81 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
49d faster than avg
Panel avg: 130d · This submission: 81d
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

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