510(k) Report

Devices descending from K131201

2 later devices reach Entuit Secure Gastrointestional Suture Anchor Set, Entuit Secure Adjustable… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152524Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable…Cook Incorporated201513
+2K251229EndoFix™Tissue Fixation SystemSoftac Medical Technologies20250—