Cleared Special

DESIGNS FOR VISION FIBEROPTIC LIGHT

K032283 · Designs For Vision, Inc. · Gastroenterology & Urology
Aug 2003
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K032283 is an FDA 510(k) clearance for the DESIGNS FOR VISION FIBEROPTIC LIGHT, a Endoscope, Fiber Optic (Class II — Special Controls, product code GDB), submitted by Designs For Vision, Inc. (North Attleboro, US). The FDA issued a Cleared decision on August 20, 2003, 27 days after receiving the submission on July 24, 2003. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K032283 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2003
Decision Date August 20, 2003
Days to Decision 27 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code GDB — Endoscope, Fiber Optic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500