510(k) Report

Devices descending from K161633

4 later devices reach Rexlon, Rexsil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture…Safepath Medical, Inc.20240—
+1K232355Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd.20240—
+1K212888Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit Sutures20220—
+1K180701SafePath Suturing SystemSafepath Medical, Inc.20181—