KNT · Tubes, Gastrointestinal (And Accessories)
Gastroenterology, Urology · 21 CFR 876.5980 · Class 2
Overview
| Product Code | KNT |
|---|---|
| Device Name | Tubes, Gastrointestinal (And Accessories) |
| 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 649)
Showing 20 most recent of 649 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250389 | XNY Disposable Gastric Calibration Tube | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | Apr 10, 2025 | SESE |
| K243228 | Flexi-Seal AIR (with ENFit Connector) | Convatec | Mar 28, 2025 | SESE |
| K242336 | hygh-tec Drainage II | Amb Medtec | Jan 17, 2025 | SESE |
| K242901 | ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40) | Tools For Surgery, LLC | Jan 10, 2025 | SESE |
| K241169 | Entarik NI Feeding Tube System | Gravitas Medical, Inc. | Nov 22, 2024 | SESE |
| K241185 | CORGRIP* SR NG/NI Tube Retention System | Avanos Medical, Inc. | Oct 25, 2024 | SESE |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950) | Avanos Medical, Inc. | Jun 6, 2024 | SESE |
| K233591 | Stylus | Degania Silicone , Ltd. | May 31, 2024 | SESE |
| K241039 | ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) | Reshape Lifesciences | May 16, 2024 | SESE |
| K234033 | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) | Boehringer Laboratories, LLC | May 6, 2024 | SESE |
| K240039 | Enteral Feeding Sets | Hangzhou Primecare Medical Co., Ltd. | Apr 17, 2024 | SESE |
| K240069 | Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) | Endolumik | Feb 8, 2024 | SESE |
| K234145 | ViSiGi 3D Gastric Sizing Tube | Boehringer Laboratories | Jan 26, 2024 | SESE |
| K222846 | AMT G-Tube Balloon Gastrostomy Feeding Device | Applied Medical Technology, Inc. | Dec 18, 2023 | SESE |
| K230206 | Entarik Feeding Tube System; Entarik Feeding Tube | Gravitas Medical, Inc. | Mar 24, 2023 | SESE |
| K222880 | Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) | Endolumik, Inc. | Mar 3, 2023 | SESE |
| K230131 | ReShape Calibration Tubes | Reshape Lifesciences | Feb 15, 2023 | SESE |
| K221400 | hygh-tec drainage | Creative Balloons GmbH | Feb 9, 2023 | SESE |
| K222085 | Standard Tapered Bougie, 38 Fr. | Standard Bariatrics, Inc. | Oct 31, 2022 | SESE |
| K212316 | DoubleChek DC-1001 | Nasogastric Feeding Solutions, Ltd. | Sep 30, 2022 | SESE |
Top Applicants
- Biosearch Medical Products, Inc. — 35 clearances
- Abbott Laboratories — 23 clearances
- Medical Innovations Corp. — 18 clearances
- Applied Medical Technology, Inc. — 16 clearances
- C.R. Bard, Inc. — 14 clearances
