510(k) Report

Devices descending from K132343

5 later devices reach Marigen Wound Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190528MariGen Wound ExtraKerecis Limited20193—
+1K153364Kerecis SecureMeshKerecis Limited20160—
+2K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+2K241080Kerecis Parvus (50207)Kerecis Limited20241—
+2K213231Kerecis SiliconeKerecis Limited20221—