Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo (K243181)
Description
Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo by Bionova Medical, Inc., an FDA 510(k) cleared unknown device.
Regulatory Information
FDA Database
View on FDA DatabasePredicate lineage for K243181
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. Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo (K243181) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240298 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo | Bionova Medical, Inc. | 2024 |
| K231937 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. | 2023 |
Trace the full predicate network for K243181
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.