FDA 510(k) Applications for Medical Device Product Code: KGC (Tube, Gastro-Enterostomy)

FDA 510(k) Applications for Medical Device Product Code "KGC"
(Tube, Gastro-Enterostomy)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K980145	APPLIED MEDICAL TECHNOLOGY, INC.	AMT DECOMPRESSION TUBES	04/10/1998
K193612	Applied Medical Technology, Inc.	AMT Suture Delivery System	03/12/2020
K120587	APPLIED MEDICAL TECHNOLOGY, INC.	AMT T-FASTENER ANCHOR KIT	05/25/2012
K242211	CoapTech Inc.	PUMA-G Pediatric System	04/29/2025
K223916	CoapTech Inc.	PUMA-G System	03/29/2023
K183057	CoapTech LLC	PUMA-G System	04/10/2019
K182832	Cook Incorporated	Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set	06/26/2019
K170323	Cook Incorporated	Entuit Start Initial Placement Gastrostomy Set	09/14/2017
K191844	Fidmi Medical Ltd	Fidmi Low Profile Enteral Feeding Device	09/30/2019
K093312	KIMBERLY-CLARK CORP.	KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM	12/08/2009
K080253	KIMBERLY-CLARK CORP.	KIMBERLY-CLARK INTRODUCER KITS	02/26/2008
K073718	MEDLINE INDUSTRIES, INC.	MEDLINE GASTROSTOMY TUBE	03/19/2008