ClearanceBrief
510(k) K260962 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Sphincterotome

ApplicantTaewoong Medical Co., Ltd., Gimpo-Si, KR
DecisionSubstantially Equivalent, May 21, 2026
ReceivedMar 23, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K260962

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.