510(k) Report

Devices descending from K090638

2 later devices reach Genadyne A4-XLR8 Wound Vacuum System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143726XLR8 Plus (XLR8+)Genadyne Biotechnologies, Inc.20150—
+1K141437XLR8 Plus (XLR8+)Genadyne Biotechnologies, Inc.20140—