510(k) Report

Devices descending from K980123

7 later devices reach Carter-Thomason Needle-Point Suture Passer Instrument Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260197Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)Suzhou Shenyun Medical Equipment Co., Ltd.20260—
+1K241111AMT Suture PasserApplied Medical Technology, Inc.20240—
+1K180701SafePath Suturing SystemSafepath Medical, Inc.20181—
+1K133414Reprocessed Closure SystemSterilmed, Inc.201401
+1K053585Vanguard Reprocessed Suture PasserAscent Healthcare Solutions200601
+1K984600Metra PS Procedure KitInlet Medical, Inc.19990—
+2K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture…Safepath Medical, Inc.20240—