Cleared Traditional

K151243 - STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] (FDA 510(k) Clearance)

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

K151243 · Stryker Endoscopy · Gastroenterology & Urology device
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Aug 2015
Decision
101d
Days
Class 2
Risk

K151243 is an FDA 510(k) clearance for the STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureter.... Classified as Light, Catheter, Fiberoptic, Glass, Ureteral (product code FCS), Class II - Special Controls.

Submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on August 20, 2015 after a review of 101 days - within the typical 510(k) review window.

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. 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.

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Submission Details

510(k) Number K151243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2015
Decision Date August 20, 2015
Days to Decision 101 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
29d faster than avg
Panel avg: 130d · This submission: 101d
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.