510(k) Report

Devices descending from K070904

109 later devices reach Antlia II Suction Pump System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K232379PREVENT KitClear Choice Therapeutics20240—
+6K213906extriCARE 1000 Negative Pressure Wound Therapy SystemAlleva Medical, Ltd.20231—
+6K221891UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20220—
+6K223041Renasys Edge (66803126)Smith & Nephew Medical Limited202223
+6K211318PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative…Smith Nephew Medical Limited20220—
+6K182722XLR8 Abdominal Wound Dressing KitGenadyne Biotechnologies20190—
+7K251646extriCARE® 1000 Negative Pressure Wound Therapy SystemAlleva Medical Devices20250—
+7K231939Renasys EdgeSmith & Nephew Medical, Ltd.20241—
+8K260646Renasys Edge (66803126)Smith & Nephew Medical, Ltd.20260—