K253662
- 510(k) number
- K253662
- Device name
- LIXI (LXOSFM1)
- Applicant
- Luwi, LLC IL · US
- Product code
- MSC — Barrier, Std, Oral Sex
- Decision date
- 2026-07-14
- Date received
- 2025-11-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253662.pdf
Official FDA record: K253662
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.