510(k) Report

Devices descending from K181582

2 later devices reach DemeTECH DemeDIOX absorbable surgical suture through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254238MINT MONO SuturesHans Biomed Corporation20260—
+1K251414Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)Feeltech Co., Ltd.20250—