510(k) Report

Devices descending from K201151

2 later devices reach O-Mec 690 Series Laparoscopes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231725Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)Hunan Endoso Life Technology Co., Ltd.20230—
+1K231003Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)Guangdong Optomedic Technologies, Inc.20230—