Cleared Traditional

URIGLOW TRANSILLUMINATING URETERIC STENT MODEL (K943801) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K943801 · Rocket of London, Ltd. · Gastroenterology & Urology device
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Aug 1995
Decision
377d
Days
Class 2
Risk

K943801 is an FDA 510(k) clearance for the URIGLOW TRANSILLUMINATING URETERIC STENT MODEL. Classified as Light, Catheter, Fiberoptic, Glass, Ureteral (product code FCS), Class II - Special Controls.

Submitted by Rocket of London, Ltd. (Tyne & Wear, GB). The FDA issued a Cleared decision on August 15, 1995 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4020 - 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. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K943801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1994
Decision Date August 15, 1995
Days to Decision 377 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
247d slower than avg
Panel avg: 130d · This submission: 377d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FCS Light, Catheter, Fiberoptic, Glass, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4020
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.