Class Class II
Intimate Rose Vaginal Dilators (K241748)
Description
Intimate Rose Vaginal Dilators by Plus EV Holdings Dba Intimate Rose, an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241748
Clearance Date2024-08-14
Clearance TypeTraditional
Product CodeHDX
Regulation Number884.3900
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241748
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. Intimate Rose Vaginal Dilators (K241748) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231430 | Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose | 2023 |
| K220035 | Milli Vaginal Dilator | Materna Medical | 2023 |
Trace the full predicate network for K241748
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.