510(k) Report

Devices descending from K983362

107 later devices reach NU-Gel * Wound Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—