510(k) Report

Devices descending from K191696

4 later devices reach Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202430Kerecis ReconstructKerecis Limited20213—
+2K251844Kerecis SurgiBind (50241)Kerecis Limited20250—
+2K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.20250—
+2K243843Tendon Protect (50242)Kerecis Limited20250—