Class Class II
Gastric Alimetry System (K223398)
Description
Gastric Alimetry System by Alimetry , Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223398
Clearance Date2023-04-27
Clearance TypeTraditional
Product CodeMYE
Regulation Number876.1735
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223398
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. Gastric Alimetry System (K223398) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213924 | Gastric Alimetry System | Alimetry , Ltd. | 2022 |
| K014269 | POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODE... | Medtronic Functional Diagnostics A/S | 2002 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232925 | Gastric Alimetry System | Alimetry , Ltd. | 2023 |
Trace the full predicate network for K223398
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.