K182915 is an FDA 510(k) clearance for the ENvizion Medical ENvue. 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 February 13, 2019, 118 days after receiving the submission on October 18, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K182915 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 2018 |
| Decision Date | February 13, 2019 |
| Days to Decision | 118 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 |