ClearanceBrief
510(k) K261522 ยท GXY Electrode, Cutaneous

BioWave BioWraps

ApplicantBiowave Corporation, Westport CT, US
DecisionSubstantially Equivalent, Jun 3, 2026
ReceivedMay 7, 2026
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K261522

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.