510(k) Report

Devices descending from K011994

118 later devices reach Acryderm Silver Anttimicrobial Wound Gel Model# a-002101 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K220286ELECTROCYN somaV3Bio Sdn. Bhd20220—
+5K222189SiOxD Wound MatrixSioxmed, LLC20222—
+5K222804Irrisept Antimicrobial Wound LavageIrrimax Corporation20220—
+5K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company20223—
+5K193583Restrata®Acera Surgical, Inc.202011
+5K181428Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc.20195—
+5K173896Microcyn Antimicrobial HydrogelSonoma Pharmaceuticals, Inc.20180—
+5K172851Microcyn Plus Antimicrobial Wound Care SolutionSonoma Pharmaceuticals, Inc.201701
+6K251757Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20260—
+6K243875Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc.20250—
+6K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+6K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+6K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+6K232847SiOxD Wound MatrixSioxmed, LLC20231—
+6K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd20222—
+6K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC20204—
+7K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)20260—
+7K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd20260—