Class Class II
Mucosal Impedance Measurement System (K233974)
Description
Mucosal Impedance Measurement System by Alandra Medical Sapi DE CV, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK233974
Clearance Date2024-09-06
Clearance TypeTraditional
Product CodeQIS
Regulation Number876.1450
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233974
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. Mucosal Impedance Measurement System (K233974) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230206 | Entarik Feeding Tube System; Entarik Feeding Tube | Gravitas Medical, Inc. | 2023 |
| K213258 | Nasogastric Feeding Tubes - ENFit Port - PVC | Cair Lgl | 2022 |
Trace the full predicate network for K233974
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.