Class Class U
ABCcolla® Collagen ADM Scaffold (K233378)
Description
ABCcolla® Collagen ADM Scaffold by Acro Biomedical Co., Ltd., an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK233378
Clearance Date2024-10-18
Clearance TypeTraditional
Product CodeKGN
FDA Database
View on FDA DatabasePredicate lineage for K233378
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. ABCcolla® Collagen ADM Scaffold (K233378) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K162348 | ABCcolla Collagen Matrix | Acro Biomedical Co., Ltd. | 2017 |
| K152033 | Cook ECM Powder | Cook Biotech Incorporated | 2015 |
Trace the full predicate network for K233378
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.