ClearanceBrief
510(k) K262353 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence

BTL-299-F

ApplicantBTL Industries, Inc., Marlborough MA, US
DecisionSubstantially Equivalent, Sep 23, 2026
ReceivedJul 10, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K262353

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.