Cleared Traditional

K933369 - CUDA PRODUCTS CORP. LIGHTSOURCES

K933369 is the FDA 510(k) clearance for CUDA PRODUCTS CORP. LIGHTSOURCES by Cuda Products Co.. It is a Class 2 Gastroenterology & Urology device (product code FCW) cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K933369 · Cuda Products Co. · Gastroenterology & Urology device
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Jan 1994
Decision
178d
Days
Class 2
Risk

K933369 is an FDA 510(k) clearance for the CUDA PRODUCTS CORP. LIGHTSOURCES. Classified as Light Source, Fiberoptic, Routine (product code FCW), Class II - Special Controls.

Submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on January 3, 1994 after a review of 178 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cuda Products Co. devices

Submission Details

510(k) Number K933369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1993
Decision Date January 03, 1994
Days to Decision 178 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 130d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FCW Light Source, Fiberoptic, Routine
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.

Regulatory Peers - FCW Light Source, Fiberoptic, Routine

All 13
Devices cleared under the same product code (FCW) and FDA review panel - the closest regulatory comparables to K933369.
ENDOSPOT
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