510(k) Report

Devices descending from K003028

2 later devices reach Cytoplast Suture; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163049GOLNIT Non-Absorbable PTFE Surgical SutureAntarma Dba Golnit Sutures20171—
+2K192088GOLNIT Non-aborbable PTFE Surgical SutureAntarma, LLC Dba Golnit Sutures20190—