CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM— 510(k) K120303

Name: FDA 510(k) clearance K120303
Creator: U.S. Food and Drug Administration
Published: 2012-06-05

Substantially Equivalent

Cybersonics, Inc.

FDA 510(k) clearance K120303 for CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM, Substantially Equivalent on 2012-06-05. Applicant: Cybersonics, Inc.. Device class: 2.

Clearance details

Applicant: Cybersonics, Inc.
Product code: Code FFK
Device class: Class 2
Regulation: 21 CFR 876.4480
Advisory panel: Gastroenterology, Urology
Date received: 2012-02-01
Decision date: 2012-06-05
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Erie, PA, US

Download summary PDF View on FDA.gov ↗

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