Clearance Summary
ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube received FDA 510(k) clearance under submission number K182915, sponsored by Envizion Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2019-02-13.
- Submission: K182915
- Applicant / Sponsor: Envizion Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2019-02-13
Classification & Regulation
This clearance is catalogued under FDA product code KNT and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.