510(k) Report

Devices descending from K130814

3 later devices reach Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+1K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+1K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—