K252005
- 510(k) number
- K252005
- Device name
- Livi Device
- Applicant
- Liviwell, Inc. NJ · US
- Product code
- HEB — Tampon, Menstrual, Unscented
- Decision date
- 2026-03-20
- Date received
- 2025-06-27
- 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: K252005.pdf
Official FDA record: K252005
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.