Class Class II
Water Solubility Human Body Lubricant (K243107)
Description
Water Solubility Human Body Lubricant by Dongguan Yanxuan Biotechnology Co., Ltd., an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243107
Clearance Date2025-05-09
Clearance TypeTraditional
Product CodeNUC
Regulation Number884.5300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243107
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Water Solubility Human Body Lubricant (K243107) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200208 | Agape Warming Personal Lubricant | CC Wellness, LLC | 2020 |
Trace the full predicate network for K243107
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.