FPD · Tube, Feeding
Gastroenterology, Urology · 21 CFR 876.5980 · Class 2
Overview
| Product Code | FPD |
|---|---|
| Device Name | Tube, Feeding |
| 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 59)
Showing 20 most recent of 59 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243361 | Nutrifit | Vygon USA | Dec 19, 2024 | SESE |
| K180236 | VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) | Vr Medical Technology Co., Ltd. | Jan 18, 2019 | SESE |
| K131590 | INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE | Philips Medical Systems | Oct 23, 2013 | SESE |
| K120815 | INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE | Philips Medical Systems | Mar 6, 2013 | SESE |
| K121105 | NUTRISAFE 2 FEEDING TUBE | Vygon Corp. | Dec 18, 2012 | SESE |
| K100163 | NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX | Vygon Corp. | Oct 13, 2011 | SESE |
| K110853 | VR MEDICAL ENTERAL ORAL SYRINGE | Vr Medical | May 13, 2011 | SESE |
| K100700 | MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES | Benlan, Inc. | Dec 13, 2010 | SESE |
| K101214 | GUARDIAN CONNECTION | Maulin Medical, LLC | Jul 23, 2010 | SESE |
| K100099 | ORAL/ENTERAL SYRINGES | Philips Children'S Medical Ventures | Jun 14, 2010 | SESE |
| K100526 | AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE | Kentec Medical, Inc. | Apr 22, 2010 | SESE |
| K091340 | THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350 | Boston Scientific Corp | Jun 9, 2009 | SESK |
| K083776 | CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S | Corpak Medsystems | Mar 5, 2009 | SESE |
| K083791 | CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S | Corpak Medsystems | Mar 4, 2009 | SESE |
| K083786 | CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB | Corpak Medsystems | Feb 20, 2009 | SESE |
| K083210 | CORFLO ANTI IV ENTERAL FEEDING TUBE | Corpak Medsystems | Dec 29, 2008 | SESE |
| K072831 | FROG | Newby-Coombs, LLC | Dec 12, 2008 | SESE |
| K082238 | NEOMED POLYURETHANE FEEDING TUBE | Neomed, Inc. | Oct 1, 2008 | SESE |
| K072881 | NEOMED Enteral FEEDING TUBE | Neomed, Inc. | Jan 9, 2008 | SESE |
| K071191 | NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT | Novartis Nutrition Corp. | Jul 23, 2007 | SESE |
Top Applicants
- Sandoz Nutrition — 6 clearances
- Corpak Medsystems — 4 clearances
- Vygon Corp. — 4 clearances
- Biosearch Medical Products, Inc. — 2 clearances
- Boston Scientific Corp — 2 clearances
