510(k) Report

Devices descending from K140415

8 later devices reach Monotex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191317StitchKitOrigami Surgical20190—
+1K173922C-PTFETM Surgical SutureCp Medical, Inc.20180—
+1K173335Gazelle PTFE and Suture Delivery DeviceDura Tap, LLC20182—
+1K160744LOOK PTFE SutureSurgical Specialties Corporation20162—
+2K233355Cypris eXact Suturing SystemCypris Medical20240—
+2K231277TissueStatDurastat, LLC20230—
+2K192088GOLNIT Non-aborbable PTFE Surgical SutureAntarma, LLC Dba Golnit Sutures20190—
+2K181578DemeTECH PTFE Nonabsorbable Surgical SutureDemetech Corporation20180—