K072476 is an FDA 510(k) clearance for the THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on December 14, 2007, 101 days after receiving the submission on September 4, 2007.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K072476 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | September 04, 2007 |
| Decision Date | December 14, 2007 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |