K051480 is an FDA 510(k) clearance for the ENTERAL FEEDING TUBE. This device is classified as a Tube, Nasogastric (Class II - Special Controls, product code BSS).
Submitted by Biosearch Medical Products, Inc. (Branchburg, US). The FDA issued a Cleared decision on October 12, 2005, 131 days after receiving the submission on June 3, 2005.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K051480 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2005 |
| Decision Date | October 12, 2005 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | BSS — Tube, Nasogastric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |