Class Class II
Unscented Tampon (K241064)
Description
Unscented Tampon by Shandong Intco Hygiene Products Co., Ltd., an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241064
Clearance Date2025-01-10
Clearance TypeTraditional
Product CodeHEB
Regulation Number884.5470
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241064
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. Unscented Tampon (K241064) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231341 | Organic cotton tampon, Viscose tampon | Zhejiang Tianqing Manufacturing Tec... | 2023 |
Trace the full predicate network for K241064
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.