510(k) Report

Devices descending from K092552

11 later devices reach Clo-Surplus P.a.D. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150916HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO…Hem Con Medical Technologies, Inc.20153—
+1K112191Healex Biosponge Wound DressingBionova Medical, Inc.20125—
+1K112961Clo-Surplus P.a.D.Scion Cardio-Vascular, Inc.20114—
+2K202830Axiostat PatchAdvamedica, Inc.20210—
+2K182811gel-e Flex+Gel-E, Inc.20191—
+2K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+3K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+3K192667gel-e Flex+ gel OTCGel-E, Inc.20190—
+4K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+5K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+5K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—