ClearanceBrief
510(k) K254192 ยท NAY System, Surgical, Computer Controlled Instrument

Senhance Ultrasonic System

ApplicantAsensus Surgical, Durham NC, US
DecisionSubstantially Equivalent, May 12, 2026
ReceivedDec 23, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K254192

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.