ClearanceBrief
510(k) K220081 ยท OTJ Laparoscopic Single Port Access Device

CORE-SPORT

ApplicantIncore Co., Ltd., Daegu, KR
DecisionSubstantially Equivalent, Sep 28, 2022
ReceivedJan 10, 2022
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K220081

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.