510(k) Report

Devices descending from K201571

3 later devices reach ACTIV.A.C. Negative Pressure Wound Therapy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253199Curasys 2 (EMDN0003)CG Bio Co., Ltd.20260—
+1K2411343M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)Kci USA, Inc.20240—
+1K230233Prospera Spectruum Negative Pressure Wound Therapy SystemDeroyal Industries, Inc.20240—