510(k) K160044 ยท FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Image1 SPIES System
| Applicant | Karl Storz Endoscopy America, Inc., El Segundo CA, US |
| Decision | Substantially Equivalent, Feb 1, 2016 |
| Received | Jan 8, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160044
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.