Tube, Nasogastric
The Tube, Nasogastric is a flexible tube inserted through the nose and advanced into the stomach, used for feeding, medication administration, or gastric drainage. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BSS, regulated under 21 CFR 876.5980 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.
Research product code BSS in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- BSS
- Device Class
- FDA class 2
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K142483 | TurboSEAL Nasogastric Aspiration Tube | Dec 19, 2014 | Substantially Equivalent | Turboseal, L.P. |
| K051480 | ENTERAL FEEDING TUBE | Oct 12, 2005 | Substantially Equivalent | Biosearch Medical Products, Inc. |
| K984629 | MOSS TUBES, INC. NASAL TUBE - MARK IV | Mar 02, 1999 | Substantially Equivalent | Moss Tubes, Inc. |
| K961711 | ASPISAFE GASTRIC TUBE | Jun 11, 1997 | Substantially Equivalent | B.Braun Medical, Inc. |
| K933596 | GASTRIC, CATHETER, IRRIGATION & ASPIRATION | Feb 13, 1995 | Substantially Equivalent | Polamedco, Inc. |
| K930510 | RADIUS ENTERAL FEEDING TUBE | Feb 01, 1995 | Substantially Equivalent | Radius Intl., Inc. |
| K935688 | AN-10S ANDERSEN TUBE WITH STYLET | Dec 30, 1994 | Substantially Equivalent | H.W. Andersen Products, Inc. |
| K934348 | TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR | Dec 23, 1994 | Substantially Equivalent | Tri-Med Specialties, Inc. |
| K905573 | XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A | Jun 19, 1991 | Substantially Equivalent | Zeon Medical Corp. |
| K910479 | ARGYLE POLYURETHANE SALEM SUMP TUBE | Apr 19, 1991 | Substantially Equivalent | Sherwood Medical Co. |
| K894870 | WILTEK NASAL BILIARY DRAINAGE SET | Dec 21, 1989 | Substantially Equivalent | Wiltek Medical, Inc. |
| K891187 | TECNOL NASO-GASTRIC TUBE HOLDER | May 30, 1989 | Substantially Equivalent | Tecnol New Jersey Wound Care, Inc. |
| K791531 | FLEXIFLO ENTERAL PUMP SET | Sep 12, 1979 | Substantially Equivalent | Abbott Laboratories |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.