Class Class II
Sutil Rich Personal Lubricant (K250629)
Description
Sutil Rich Personal Lubricant by Hathor Professional Skincare , Ltd., an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250629
Clearance Date2025-05-02
Clearance TypeTraditional
Product CodeNUC
Regulation Number884.5300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250629
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. Sutil Rich Personal Lubricant (K250629) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241443 | Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 001... | Hathor Professional Skincare , Ltd. | 2025 |
| K211998 | Desnuda Reflect | Good Clean Love, Inc. | 2021 |
Trace the full predicate network for K250629
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.