Class Class II
Sentimag System (K222832)
Description
Sentimag System by Endomagnetics Ltd.,, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222832
Clearance Date2023-01-21
Clearance TypeTraditional
Product CodeNEU
Regulation Number878.4300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222832
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. Sentimag System (K222832) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K173587 | Magseed Magnetic Marker Systtem | Endomagnetics Ltd., | 2018 |
| K163541 | Magseed Magnetic Marker System | Endomagnetics Ltd., | 2017 |
| K153044 | Sentimag System, Sentimark Magnetic Marker Systerm | Endomagnetics Ltd., | 2016 |
Trace the full predicate network for K222832
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.