Cleared Special

DESIGNS FOR VISION FIBEROPTIC LIGHT (K032283) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K032283 · Designs For Vision, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Aug 2003
Decision
27d
Days
Class 2
Risk

K032283 is an FDA 510(k) clearance for the DESIGNS FOR VISION FIBEROPTIC LIGHT. Classified as Endoscope, Fiber Optic (product code GDB), Class II - Special Controls.

Submitted by Designs For Vision, Inc. (North Attleboro, US). The FDA issued a Cleared decision on August 20, 2003 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Designs For Vision, Inc. devices

Submission Details

510(k) Number K032283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 130d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GDB Endoscope, Fiber Optic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.