Class Class II
Wee Bell (K221356)
Description
Wee Bell by Wee Medical, an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221356
Clearance Date2023-02-02
Clearance TypeTraditional
Product CodeHFX
Regulation Number884.4530
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221356
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. Wee Bell (K221356) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K151095 | Circumplast Circumcision Device | Novadien Healthcare | 2015 |
Trace the full predicate network for K221356
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.