K191387 is an FDA 510(k) clearance for the ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Envizion Medical , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on June 14, 2019, 21 days after receiving the submission on May 24, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K191387 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2019 |
| Decision Date | June 14, 2019 |
| Days to Decision | 21 days |
| Submission Type | Special |
| 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 |