Tube, Nasogastric
FDA product code BSS · Class II (moderate risk) · 21 CFR 876.5980 · Gastroenterology, Urology
13510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Abbott Laboratories 1
- Tecnol New Jersey Wound Care, Inc. 1
- Wiltek Medical, Inc. 1
- Sherwood Medical Co. 1
- Zeon Medical Corp. 1
- Tri-Med Specialties, Inc. 1
- H.W. Andersen Products, Inc. 1
- Radius Intl., Inc. 1
- Polamedco, Inc. 1
- B. Braun Medical, Inc. 1
- Moss Tubes, Inc. 1
- Biosearch Medical Products, Inc. 1
- Turboseal, L.P. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142483 | TurboSEAL Nasogastric Aspiration TubeBSS · Traditional | Turboseal, L.P. | 12/19/2014SE |
| K051480 | Enteral Feeding TubeBSS · Traditional | Biosearch Medical Products, Inc. | 10/12/2005SE |
| K984629 | Moss Tubes, Inc. Nasal Tube - Mark IVBSS · Traditional | Moss Tubes, Inc. | 03/02/1999SE |
| K961711 | Aspisafe Gastric TubeBSS · Traditional | B.Braun Medical, Inc. | 06/11/1997SE |
| K933596 | Gastric, Catheter, Irrigation & AspirationBSS · Traditional | Polamedco, Inc. | 02/13/1995SE |
| K930510 | Radius Enteral Feeding TubeBSS · Traditional | Radius Intl., Inc. | 02/01/1995SE |
| K935688 | AN-10S Andersen Tube with StyletBSS · Traditional | H.W. Andersen Products, Inc. | 12/30/1994SE |
| K934348 | Tri-Med Quick-Step Gastric Lavage Tube Sizes 18FR, 22FR, 32FRBSS · Traditional | Tri-Med Specialties, Inc. | 12/23/1994SE |
| K905573 | Xemex Enteral Nutrition Catheter Nasogas. Type aBSS · Traditional | Zeon Medical Corp. | 06/19/1991SE |
| K910479 | Argyle Polyurethane Salem Sump TubeBSS · Traditional | Sherwood Medical Co. | 04/19/1991SE |
| K894870 | Wiltek Nasal Biliary Drainage SetBSS · Traditional | Wiltek Medical, Inc. | 12/21/1989SE |
| K891187 | Tecnol Naso-Gastric Tube HolderBSS · Traditional | Tecnol New Jersey Wound Care, Inc. | 05/30/1989SE |
| K791531 | Flexiflo Enteral Pump SetBSS · Traditional | Abbott Laboratories | 09/12/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0794-2024 Class II | Bard Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | C.R. Bard Inc | 12/20/2023Open, Classified |
| Z-0793-2024 Class II | Bard Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | C.R. Bard Inc | 12/20/2023Open, Classified |
| Z-0792-2024 Class II | Bard Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | C.R. Bard Inc | 12/20/2023Open, Classified |
| Z-0791-2024 Class II | Bard Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | C.R. Bard Inc | 12/20/2023Open, Classified |
| Z-0790-2024 Class II | Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | C.R. Bard Inc | 12/20/2023Open, Classified |