KGC · Tube, Gastro-Enterostomy
Gastroenterology, Urology · 21 CFR 876.5980 · Class 2
Overview
| Product Code | KGC |
|---|---|
| Device Name | Tube, Gastro-Enterostomy |
| Regulation | 21 CFR 876.5980 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).
Classification Rationale
(1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Special Controls
*Classification.* (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Recent Cleared Devices (20 of 26)
Showing 20 most recent of 26 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242211 | PUMA-G Pediatric System | Coaptech, Inc. | Apr 29, 2025 | SESE |
| K223916 | PUMA-G System | Coaptech, Inc. | Mar 29, 2023 | SESE |
| K193612 | AMT Suture Delivery System | Applied Medical Technology, Inc. | Mar 12, 2020 | SESE |
| K191844 | Fidmi Low Profile Enteral Feeding Device | Fidmi Medical, Ltd. | Sep 30, 2019 | SESE |
| K182832 | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set | Cook Incorporated | Jun 26, 2019 | SESK |
| K183057 | PUMA-G System | Coaptech, LLC | Apr 10, 2019 | SESE |
| K170323 | Entuit Start Initial Placement Gastrostomy Set | Cook Incorporated | Sep 14, 2017 | SESE |
| K120587 | AMT T-FASTENER ANCHOR KIT | Applied Medical Technology, Inc. | May 25, 2012 | SESK |
| K093312 | KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM | Kimberly-Clark Corp. | Dec 8, 2009 | SESE |
| K073718 | MEDLINE GASTROSTOMY TUBE | Medline Industries, Inc. | Mar 19, 2008 | SESE |
| K080253 | KIMBERLY-CLARK INTRODUCER KITS | Kimberly-Clark Corp. | Feb 26, 2008 | SESK |
| K980145 | AMT DECOMPRESSION TUBES | Applied Medical Technology, Inc. | Apr 10, 1998 | SESE |
| K910492 | BARD REPLACEMENT GASTROSTOMY TUBE | C.R. Bard, Inc. | Jul 24, 1991 | SESE |
| K910584 | ONE STEP BUTTON(TM) | Applied Medical Technologies | May 23, 1991 | SESE |
| K904779 | BUTTON REPLACEMENT GASTROSTOMY DEVICE | C.R. Bard, Inc. | Jan 18, 1991 | SESE |
| K904801 | ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE | Orion Life Systems, Inc. | Jan 16, 1991 | SESE |
| K903086 | TUBE GASTROSTOMY | Knight Medical, Inc. | Nov 20, 1990 | SESE |
| K903036 | P.R.G. GUIDEWIRE PLACEMENT SYSTEM | Applied Medical Technologies | Nov 19, 1990 | SESD |
| K901795 | GASTROSTOMY FEEDING CATHETER | Southside Biotechnology | Aug 8, 1990 | SESK |
| K901791 | PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING CATH. | Southside Biotechnology | Aug 8, 1990 | SESK |
Top Applicants
- Applied Medical Technologies — 3 clearances
- Applied Medical Technology, Inc. — 3 clearances
- C.R. Bard, Inc. — 2 clearances
- Coaptech, Inc. — 2 clearances
- Cook Incorporated — 2 clearances
