ClearanceBrief
510(k) K253662 ยท MSC Barrier, Std, Oral Sex

LIXI (LXOSFM1)

ApplicantLuwi, LLC, Mount Prospect IL, US
DecisionSubstantially Equivalent, Jul 14, 2026
ReceivedNov 20, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K253662

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.