ClearanceBrief
510(k) K254056 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories

THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)

ApplicantOlympus Medical Systems Corp., Hachioji-Shi, JP
DecisionSubstantially Equivalent, Jul 1, 2026
ReceivedDec 17, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K254056

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.