510(k) K181439 ยท FBN Choledochoscope And Accessories, Flexible/Rigid
SpyGlass DS and DS II Direct Visualization System
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Aug 23, 2018 |
| Received | Jun 1, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181439
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.