Enteral Feeding Tube
FDA 510(k) K051480 · Biosearch Medical Products, Inc.
510(k) numberK051480
Submission
- Device name
- Enteral Feeding Tube
- Applicant
- Biosearch Medical Products, Inc.
Branchburg, NJ, US - Received
- June 3, 2005
- Decision date
- October 12, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BSS – Tube, Nasogastric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code BSS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142483 | TurboSEAL Nasogastric Aspiration TubeBSS · Traditional | Turboseal, L.P. | 12/19/2014SE |
| 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 |
More from Wiltek Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970145 | Perineometer & Vaginal Probe (Biofeedback Monitor #20 and Vaginal Probe)HIR · Traditional | 08/11/1997SE |
| K964871 | Biosearch Syring Flushing/Cleaning Pump for Biosearch Endoscopic InstrumentsFEB · Traditional | 03/03/1997SE |
| K951260 | Urinary Intermittent Catheters W/O Hydromer Hydrophilic LubricantKOD · Traditional | 09/27/1995SE |
| K944614 | Mega-Brush, Endoscopic Mass Cytology - Celluar Retrieval SystemFDX · Traditional | 04/05/1995SE |
| K932295 | Non-Balloon Replacement Gastrostomy KitKNT · Traditional | 09/08/1994SE |
| K935045 | Biosearch Laproscopic Gastronomy CatheterKNT · Traditional | 08/19/1994SE |
| K923002 | Enteroclysis TubeKNT · Traditional | 06/28/1994SESK |
| K934193 | Cell-Mate(Tm) Mass Cytology-Cellular Retrieval SystEOX · Traditional | 11/19/1993SE |
| K922987 | Lapstick Laparoscopic Sponge Stick/ Blunt Dissec.GCJ · Traditional | 04/23/1993SE |
| K923474 | Low Profile Gastromstomy DeviceKNT · Traditional | 01/05/1993SESK |
Questions and answers
When was Enteral Feeding Tube cleared by the FDA?
Enteral Feeding Tube (K051480) received a 510(k) decision of Substantially Equivalent on October 12, 2005, 131 days after the submission was received.
What is the product code of K051480?
The FDA product code is BSS – Tube, Nasogastric, a Class II (moderate risk) device regulated under 21 CFR 876.5980.