Cleared Traditional

VIADUCT MINISCOPE AND ACCESSORIES

K040949 · Acueity, Inc. · Gastroenterology & Urology

May 2004

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K040949 is an FDA 510(k) clearance for the VIADUCT MINISCOPE AND ACCESSORIES, a Light Source, Endoscope, Xenon Arc (Class II — Special Controls, product code GCT), submitted by Acueity, Inc. (Palo Alto, US). The FDA issued a Cleared decision on May 7, 2004, 25 days after receiving the submission on April 12, 2004. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K040949 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 2004
Decision Date	May 07, 2004
Days to Decision	25 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF