K243107
- 510(k) number
- K243107
- Device name
- Water Solubility Human Body Lubricant
- Applicant
- Dongguan Yanxuan Biotechnology Co., Ltd. CN
- Product code
- NUC — Lubricant, Personal
- Decision date
- 2025-05-09
- Date received
- 2024-09-30
- 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: K243107.pdf
Official FDA record: K243107
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.