Class Class U
Kerecis Parvus (50207) (K241080)
Description
Kerecis Parvus (50207) by Kerecis Limited, an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK241080
Clearance Date2024-08-21
Clearance TypeTraditional
Product CodeKGN
FDA Database
View on FDA DatabasePredicate lineage for K241080
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. Kerecis Parvus (50207) (K241080) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190528 | MariGen Wound Extra | Kerecis Limited | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251845 | Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus | Kerecis Limited | 2025 |
Trace the full predicate network for K241080
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.