ClearanceBrief
510(k) K180096 ยท HIH Hysteroscope (And Accessories)

GDT-1000 System

ApplicantAcuvu, Inc., Redwood City CA, US
DecisionSubstantially Equivalent, Apr 16, 2018
ReceivedJan 16, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K180096

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.