510(k) Report

Devices descending from K080253

10 later devices reach Kimberly-Clark Introducer Kits through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170323Entuit Start Initial Placement Gastrostomy SetCook Incorporated20170—
+1K100173Iyunni 3ID Tri-Funnel Feeding Tube KitSainath Intellectual Properties, LLC20100—
+1K093312Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy Fasteners, Enternal Access…Kimberly-Clark Corp.20095—
+1K092049Iyunni 3ID Tri-Funnel Gastrostomy Tube KitSainath Intellectual Properties, LLC20092—
+2K183057PUMA-G SystemCoaptech, LLC20192—
+2K170020Peel-Away Introducer SetCook Incorporated20171—
+2K102572Iyunni 3ID Suprapubic Cystostomy Tube KitSainath Intellectual Properties, LLC20100—
+3K223916PUMA-G SystemCoaptech, Inc.20231—
+3K173685Peel-Away Introducer SetCook Incorporated20170—
+4K242211PUMA-G Pediatric SystemCoaptech, Inc.20250—