510(k) K160845 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, May 3, 2016 |
| Received | Mar 28, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160845
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.