510(k) Report

Devices descending from K190528

3 later devices reach MariGen Wound Extra through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+1K241080Kerecis Parvus (50207)Kerecis Limited20241—
+1K213231Kerecis SiliconeKerecis Limited20221—