Class Class II
Phasix ST Umbilical Hernia Patch (K243241)
Description
Phasix ST Umbilical Hernia Patch by Davol, Inc., A Subsidiary of C.R. Bard, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243241
Clearance Date2025-02-19
Clearance TypeTraditional
Product CodeOWT
Regulation Number878.3300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243241
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. Phasix ST Umbilical Hernia Patch (K243241) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190185 | Phasix ST Mesh with Open Positioning System | C.R. Bard, Inc. | 2019 |
| K143380 | Phasix ST Mesh | C.R. Bard, Inc. | 2015 |
| K142818 | Phasix Mesh | C. R. Bard | 2015 |
| K101928 | VENTRALEX ST HERNIA PATCH | C.R. Bard, Inc. | 2011 |
Trace the full predicate network for K243241
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.