Class Class II
troCarWash™ System (K222695)
Description
troCarWash™ System by Biotex, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222695
Clearance Date2023-02-17
Clearance TypeTraditional
Product CodeOCX
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222695
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. troCarWash™ System (K222695) cites 0 predicate devices and is itself cited by 1 later device.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233442 | troCarWash System | Biotex, Inc. | 2024 |
Trace the full predicate network for K222695
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.