Cleared Special

CYBERWAND STERILE PADS, MODEL: CW-RBPBX

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

About This 510(k) Submission

K072422 is an FDA 510(k) clearance for the CYBERWAND STERILE PADS, MODEL: CW-RBPBX, a Lithotriptor, Electro-hydraulic (Class II — Special Controls, product code FFK), submitted by Cybersonics, Inc. (Erie, US). The FDA issued a Cleared decision on October 24, 2007, 57 days after receiving the submission on August 28, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4480.

Submission Details

510(k) Number K072422 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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