Class Class U
Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander (K243836)
Description
Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander by Mentor Worldwide, LLC, an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK243836
Clearance Date2025-01-12
Clearance TypeSpecial
Product CodeLCJ
FDA Database
View on FDA DatabasePredicate lineage for K243836
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. Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander (K243836) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241918 | MENTOR CPX4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC | 2024 |
| K152496 | CPX 4 Breast Tissue Expander | Mentor Worldwide, LLC | 2016 |
Trace the full predicate network for K243836
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.