510(k) K142922 ยท FBN Choledochoscope And Accessories, Flexible/Rigid
SpyGlass DS Direct Visualization System
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Jan 16, 2015 |
| Received | Oct 8, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142922
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2017 | Boston Scientific Corporation SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600 Terminated |
FBN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.