Cleared Special

CYBERWAND LITHOTRIPTER

K102169 · Cybersonics, Inc. · Gastroenterology & Urology
Aug 2010
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K102169 is an FDA 510(k) clearance for the CYBERWAND LITHOTRIPTER, a Lithotriptor, Electro-hydraulic (Class II — Special Controls, product code FFK), submitted by Cybersonics, Inc. (Erie, US). The FDA issued a Cleared decision on August 30, 2010, 28 days after receiving the submission on August 2, 2010. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4480.

Submission Details

510(k) Number K102169 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code FFK — Lithotriptor, Electro-hydraulic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4480

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