ClearanceBrief
510(k) K243053 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument

Navient Image Guided Navigation System (ENT) (955-NC-NC)

ApplicantClaronav, Toronto, CA
DecisionSubstantially Equivalent, Jun 20, 2025
ReceivedSep 27, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K243053

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.