Clearance Summary
ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube received FDA 510(k) clearance under submission number K191387, sponsored by Envizion Medical , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2019-06-14.
- Submission: K191387
- Applicant / Sponsor: Envizion Medical , Ltd.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2019-06-14
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.