510(k) Report

Devices descending from K982646

5 later devices reach Ailee Sutures and Ailee Needles through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161633Rexlon, RexsilSm Eng Co., Ltd.20174—
+2K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture…Safepath Medical, Inc.20240—
+2K232355Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd.20240—
+2K212888Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit Sutures20220—
+2K180701SafePath Suturing SystemSafepath Medical, Inc.20181—