K180236 is an FDA 510(k) clearance for the VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES). This device is classified as a Tube, Feeding (Class II - Special Controls, product code FPD).
Submitted by Vr Medical Technology Co., Ltd. (Zhouzhuang, CN). The FDA issued a Cleared decision on January 18, 2019, 354 days after receiving the submission on January 29, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K180236 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 2018 |
| Decision Date | January 18, 2019 |
| Days to Decision | 354 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FPD — Tube, Feeding |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |