K240039 is an FDA 510(k) clearance for the Enteral Feeding Sets. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Hangzhou Primecare Medical Co., Ltd. (Hang Zhou, CN). The FDA issued a Cleared decision on April 17, 2024, 103 days after receiving the submission on January 5, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K240039 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 2024 |
| Decision Date | April 17, 2024 |
| Days to Decision | 103 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 |