Class Class II
Fecobionics Anorectal System (K242666)
Description
Fecobionics Anorectal System by Gi Bionics, LLC, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242666
Clearance Date2025-02-12
Clearance TypeTraditional
Product CodeKLA
Regulation Number876.1725
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242666
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. Fecobionics Anorectal System (K242666) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K180135 | THD Anopress with THD SensyProbe | Thd Spa | 2018 |
Trace the full predicate network for K242666
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.