The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Infrared Illumination System (iris) [aim Light Source And Iris Ureteral Kit].
| Device ID | K151243 |
| 510k Number | K151243 |
| Device Name: | STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source And IRIS Ureteral Kit] |
| Classification | Light, Catheter, Fiberoptic, Glass, Ureteral |
| Applicant | Stryker Endoscopy 5900 Optical Ct San Jose, CA 95138 |
| Contact | Golnaz Moeini |
| Correspondent | Golnaz Moeini Stryker Endoscopy 5900 Optical Ct San Jose, CA 95138 |
| Product Code | FCS |
| CFR Regulation Number | 876.4020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-11 |
| Decision Date | 2015-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613327174817 | K151243 | 000 |