510(k) K253662 ยท MSC Barrier, Std, Oral Sex
LIXI (LXOSFM1)
| Applicant | Luwi, LLC, Mount Prospect IL, US |
| Decision | Substantially Equivalent, Jul 14, 2026 |
| Received | Nov 20, 2025 |
| Type | Traditional |
| FDA record | Open 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.