ClearanceBrief
510(k) K183636 ยท FBN Choledochoscope And Accessories, Flexible/Rigid

SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller

ApplicantBoston Scientific Corporation, Marlboro MA, US
DecisionSubstantially Equivalent, Jan 22, 2019
ReceivedDec 26, 2018
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K183636

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.