MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs (K242963)
Description
MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs by Mentor Worldwide, LLC, an FDA 510(k) cleared unknown device.
Regulatory Information
FDA Database
View on FDA DatabasePredicate lineage for K242963
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™ PliaForm™ Breast Tissue Expander w/ Suture Tabs (K242963) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K161176 | ARTOURA Breast Tissue Expanders with Smooth Surface | Mentor Worldwide, LLC | 2016 |
Trace the full predicate network for K242963
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.