K252914
- 510(k) number
- K252914
- Device name
- Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)
- Applicant
- Hathor Professional Skincare , Ltd. CA
- Product code
- NUC — Lubricant, Personal
- Decision date
- 2026-06-09
- Date received
- 2025-09-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K252914.pdf
Official FDA record: K252914
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.