ClearanceBrief
510(k) K232314 ยท FDS Gastroscope And Accessories, Flexible/Rigid

Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)

ApplicantFUJIFILM Healthcare Americas Corporation, Lexington MA, US
DecisionSubstantially Equivalent, Sep 1, 2023
ReceivedAug 2, 2023
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K232314

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.