ClearanceBrief
510(k) K163492 ยท FDF Colonoscope And Accessories, Flexible/Rigid

Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear

ApplicantUnited States Endoscopy Group, Inc., Mentor OH, US
DecisionSubstantially Equivalent, Jan 6, 2017
ReceivedDec 13, 2016
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K163492

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.