PIF · Gastrointestinal Tubes With Enteral Specific Connectors
Gastroenterology, Urology · 21 CFR 876.5980 · Class 2
Overview
| Product Code | PIF |
|---|---|
| Device Name | Gastrointestinal Tubes With Enteral Specific Connectors |
| Regulation | 21 CFR 876.5980 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
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 50)
Showing 20 most recent of 50 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254170 | Percutaneous Endoscopic Gastrostomy (PEG) Kit | Degania Silicone , Ltd. | Mar 20, 2026 | SESE |
| K242917 | Enteral Drainage System, Enteral Medicine straw | HMC Premedical S.p.A. | Jun 18, 2025 | SESE |
| K250481 | Extension Feeding Set with ENFit Connectors | SKY Medical, a.s. | Apr 18, 2025 | SESE |
| K240052 | Disposable Enteral Feeding Sets | Beijing L&Z Medical Technology Development Co., Ltd. | Jul 3, 2024 | SESE |
| K233034 | Mobility+ Enteral Feeding System OTC | Rockfield Medical | Apr 12, 2024 | SESE |
| K230326 | ENFit to ENFit Extension Sets | Vesco Medical | Nov 2, 2023 | SESE |
| K232046 | Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection | Xeridiem Medical Devices, A Spectrum Plastics Group Company | Oct 6, 2023 | SESE |
| K222773 | Feeding Tube | Anhui Tiankang Medical Technology Co., Ltd. | Aug 17, 2023 | SESE |
| K223683 | EnteraLoc Flow | Vonco Products | Jul 10, 2023 | SESE |
| K222678 | Mobility+ Enteral Feeding System | Rockfield Medical | Oct 27, 2022 | SESE |
| K213258 | Nasogastric Feeding Tubes - ENFit Port - PVC | Cair Lgl | Jun 9, 2022 | SESE |
| K213174 | Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection | Cardinalhealth | May 19, 2022 | SESE |
| K213356 | Entuit PEG, Entuit PEGJ | Wilson-Cook Medical, Inc. | Jan 20, 2022 | SESD |
| K210854 | Enteral Feeding Set | Kb Medical (Group), Inc. | Nov 16, 2021 | SESE |
| K210598 | Pediatric Nasogastric Feeding Tubes - Single ENFit Port | Cair Lgl | Nov 2, 2021 | SESE |
| K203633 | Enteral Extension Sets | GBUK Group, Ltd. | Aug 19, 2021 | SESE |
| K210971 | EnteraLoc Flow | Vonco Products | Aug 18, 2021 | SESE |
| K201741 | Gabriel 3 Way EnFit Valve | Syncro Medical Innovations, Inc. | Nov 5, 2020 | SESE |
| K202357 | Nutricare Clear-ISOSAF Nasogastric Feeding Tube | Three Circles Consulting Limited | Oct 1, 2020 | SESE |
| K192991 | Vesco Medical Extension Feeding Set | Vesco Medical, LLC | Aug 3, 2020 | SESE |
Top Applicants
- Covidien — 3 clearances
- Medline Industries, Inc. — 3 clearances
- Cair Lgl — 2 clearances
- Cardinalhealth — 2 clearances
- Cedic S.R.L. — 2 clearances
