510(k) Report

Devices descending from K180205

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building20260—
+1K190028UNO 30Genadyne Biotechnologies20201—
+2K221891UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20220—