510(k) Report

Devices descending from K143497

3 later devices reach Safety Auto-Disable Syrine with Needle (Auto-Lock) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231727Sterile Auto-Disable Syringes with/without Needle for Single UseWepon Medical Technology Co., Ltd.20230—
+1K210229Sterile Auto-Disable Syringes with/without Needle for Single UseZhejiang Kangkang Medical-Devices Co., Ltd.20220—
+1K211210Sterile Auto-Disable Syringes with/without Needle for Single UseAzur Medical Company, Inc.20220—