Class Class II
ELITONE Urge Urinary Incontinence Device (K223884)
Description
ELITONE Urge Urinary Incontinence Device by Elidah, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223884
Clearance Date2023-02-24
Clearance TypeTraditional
Product CodeQAJ
Regulation Number876.5330
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223884
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. ELITONE Urge Urinary Incontinence Device (K223884) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K183585 | Elitone Device | Elidah, Inc. | 2019 |
Trace the full predicate network for K223884
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.