510(k) Report

Devices descending from K093312

5 later devices reach Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy Fasteners, Enternal… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183057PUMA-G SystemCoaptech, LLC20192—
+1K170020Peel-Away Introducer SetCook Incorporated20171—
+2K223916PUMA-G SystemCoaptech, Inc.20231—
+2K173685Peel-Away Introducer SetCook Incorporated20170—
+3K242211PUMA-G Pediatric SystemCoaptech, Inc.20250—