KGC · Class II · 21 CFR 876.5980

FDA Product Code KGC: Tube, Gastro-enterostomy

Leading manufacturers include Kimberly-Clark Corp., Cook Incorporated and Coaptech, Inc..

26
Total
26
Cleared
114d
Avg days
1978
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 274d recently vs 108d historically

FDA 510(k) Cleared Tube, Gastro-enterostomy Devices (Product Code KGC)

26 devices
1–24 of 26
Cleared Apr 29, 2025
PUMA-G Pediatric System
K242211
Coaptech, Inc.
Gastroenterology & Urology · 274d
Cleared Mar 29, 2023
PUMA-G System
K223916
Coaptech, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 12, 2020
AMT Suture Delivery System
K193612
Applied Medical Technology, Inc.
Gastroenterology & Urology · 77d
Cleared Sep 30, 2019
Fidmi Low Profile Enteral Feeding Device
K191844
Fidmi Medical, Ltd.
Gastroenterology & Urology · 83d
Cleared Jun 26, 2019
Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set
K182832
Cook Incorporated
Gastroenterology & Urology · 260d
Cleared Apr 10, 2019
PUMA-G System
K183057
Coaptech, LLC
Gastroenterology & Urology · 159d
Cleared Sep 14, 2017
Entuit Start Initial Placement Gastrostomy Set
K170323
Cook Incorporated
Gastroenterology & Urology · 225d
Cleared Dec 08, 2009
KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM
K093312
Kimberly-Clark Corp.
Gastroenterology & Urology · 47d
Cleared Mar 19, 2008
MEDLINE GASTROSTOMY TUBE
K073718
Medline Industries, Inc.
Gastroenterology & Urology · 79d
Cleared Feb 26, 2008
KIMBERLY-CLARK INTRODUCER KITS
K080253
Kimberly-Clark Corp.
Gastroenterology & Urology · 26d
Cleared Jul 24, 1991
BARD REPLACEMENT GASTROSTOMY TUBE
K910492
C.R. Bard, Inc.
Gastroenterology & Urology · 169d
Cleared Jan 18, 1991
BUTTON REPLACEMENT GASTROSTOMY DEVICE
K904779
C.R. Bard, Inc.
Gastroenterology & Urology · 88d
Cleared Jan 16, 1991
ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE
K904801
Orion Life Systems, Inc.
Gastroenterology & Urology · 84d

About Product Code KGC - Regulatory Context

510(k) Submission Activity

26 total 510(k) submissions under product code KGC since 1978, with 26 receiving FDA clearance (average review time: 114 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - KGC Product Code

Recent submissions under KGC have taken an average of 274 days to reach a decision - up from 108 days historically. Manufacturers should account for longer review timelines in current project planning.

KGC devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →