K240965 is an FDA 510(k) clearance for the CORTRAK* 2 Enteral Access System (20-0950). This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Avanos Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on June 6, 2024, 58 days after receiving the submission on April 9, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K240965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2024 |
| Decision Date | June 06, 2024 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KNT - Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |