Class Class U
Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus (K251845)
Description
Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus by Kerecis Limited, an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK251845
Clearance Date2025-07-16
Clearance TypeSpecial
Product CodeKGN
FDA Database
View on FDA DatabasePredicate lineage for K251845
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. Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus (K251845) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241080 | Kerecis Parvus (50207) | Kerecis Limited | 2024 |
| K213231 | Kerecis Silicone | Kerecis Limited | 2022 |
| K190528 | MariGen Wound Extra | Kerecis Limited | 2019 |
Trace the full predicate network for K251845
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.