510(k) Report

Devices descending from K921370

11 later devices reach Mic Gastro-Enterostomy Tube Modification through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080253Kimberly-Clark Introducer KitsKimberly-Clark Corp.200810—
+2K170323Entuit Start Initial Placement Gastrostomy SetCook Incorporated20170—
+2K100173Iyunni 3ID Tri-Funnel Feeding Tube KitSainath Intellectual Properties, LLC20100—
+2K093312Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy Fasteners, Enternal Access…Kimberly-Clark Corp.20095—
+2K092049Iyunni 3ID Tri-Funnel Gastrostomy Tube KitSainath Intellectual Properties, LLC20092—
+3K183057PUMA-G SystemCoaptech, LLC20192—
+3K170020Peel-Away Introducer SetCook Incorporated20171—
+3K102572Iyunni 3ID Suprapubic Cystostomy Tube KitSainath Intellectual Properties, LLC20100—
+4K223916PUMA-G SystemCoaptech, Inc.20231—
+4K173685Peel-Away Introducer SetCook Incorporated20170—
+5K242211PUMA-G Pediatric SystemCoaptech, Inc.20250—