510(k) Report

Devices descending from K123961

4 later devices reach Sentrex Biosponge MPD through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+2K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+3K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+3K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—