ClearanceBrief
510(k) K193118 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument

TGS Guidewire and updated Scopis Software

ApplicantStryker Ent, Plymouth MN, US
DecisionSubstantially Equivalent, Feb 21, 2020
ReceivedNov 12, 2019
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K193118

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.