Class Class II
Kerecis SurgiBind (50241) (K251844)
Description
Kerecis SurgiBind (50241) by Kerecis Limited, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251844
Clearance Date2025-07-15
Clearance TypeSpecial
Product CodeOXH
Regulation Number878.3300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251844
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 SurgiBind (50241) (K251844) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202430 | Kerecis Reconstruct | Kerecis Limited | 2021 |
| K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodes... | Cook Biotech Incorporated | 2019 |
Trace the full predicate network for K251844
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.