Cleared Traditional

STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]

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

About This 510(k) Submission

K151243 is an FDA 510(k) clearance for the STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit], a Light, Catheter, Fiberoptic, Glass, Ureteral (Class II — Special Controls, product code FCS), submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on August 20, 2015, 101 days after receiving the submission on May 11, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4020.

Submission Details

510(k) Number K151243 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code FCS — Light, Catheter, Fiberoptic, Glass, Ureteral
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4020

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