K151243 is an FDA 510(k) clearance for the STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]. This device is classified as 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 FDA review panel. Regulated under 21 CFR 876.4020.
| 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 |
| Product Code | FCS — Light, Catheter, Fiberoptic, Glass, Ureteral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4020 |