510(k) Report

Devices descending from K063531

2 later devices reach Series 3 Lotus Laparoscopic Ultrasound Surgery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151101Lotus Series 4 Ultrasonic Surgical System & AccessoriesSra Developments, Ltd.20151—
+2K221102LOTUS Series 4 Enhanced Shears, LOTUS Series 5Sra Developments, Ltd.20220—