510(k) Report

Devices descending from K082676

11 later devices reach Genadyne A4 Wound Vacuum System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140022Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister 250-ML, Nisus NPWT…Cork Medical Products, LLC20145—
+1K132004NPWT Wound Dressing Kit- Medium, NPWT Wound Dressing Kit- LargeCreo Quality, LLC20141—
+1K090638Genadyne A4-XLR8 Wound Vacuum SystemGenadyne Biotechnologies, Inc.20092—
+2K243187Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)Cork Medical20251—
+2K230677Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)Cork Medical20231—
+2K203693Nisus Touch Negative Pressure Wound Therapy PumpCork Medical Products, LLC20210—
+2K182458Longterm NPWT Foam Dressing KitZhejiang Longterm Medical Technology Co., Ltd.20190—
+2K143726XLR8 Plus (XLR8+)Genadyne Biotechnologies, Inc.20150—
+2K141437XLR8 Plus (XLR8+)Genadyne Biotechnologies, Inc.20140—
+3K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical20260—
+3K241061VERSA Negative Pressure Wound Therapy System (VCMPP-100)Cork Medical20240—