510(k) K151243 ยท FCS Light, Catheter, Fiberoptic, Glass, Ureteral
STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]
| Applicant | Stryker Endoscopy, San Jose CA, US |
| Decision | Substantially Equivalent, Aug 20, 2015 |
| Received | May 11, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151243
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.