510(k) Report

Devices descending from K173335

2 later devices reach Gazelle PTFE and Suture Delivery Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231277TissueStatDurastat, LLC20230—
+1K192088GOLNIT Non-aborbable PTFE Surgical SutureAntarma, LLC Dba Golnit Sutures20190—