510(k) Report

Devices descending from K991202

112 later devices reach Modification to Woun'dres through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K173896Microcyn Antimicrobial HydrogelSonoma Pharmaceuticals, Inc.20180—
+6K172851Microcyn Plus Antimicrobial Wound Care SolutionSonoma Pharmaceuticals, Inc.201701
+7K251757Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20260—
+7K243875Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc.20250—
+7K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+7K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+7K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+7K232847SiOxD Wound MatrixSioxmed, LLC20231—
+7K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd20222—
+7K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC20204—
+8K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)20260—
+8K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd20260—