Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube

K-Number: K182915 · 2019-02-13

ApplicantEnvizion Medical , Ltd.
Decision Date2019-02-13
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube is a medical device manufactured by Envizion Medical , Ltd.. It received FDA 510(k) clearance on 2019-02-13 under approval number K182915. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube?

ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube is a medical device that received FDA 510(k) clearance on 2019-02-13. It is manufactured by Envizion Medical , Ltd.. The 510(k) number is K182915.

When was ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube approved by the FDA?

ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube received FDA 510(k) clearance on 2019-02-13, under approval number K182915.

What company makes ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube?

ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube is manufactured by Envizion Medical , Ltd..

What is the FDA product code for ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube?

The FDA product code for ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube is KNT.

Related Clinical Trials

NCT06328894 Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients COMPLETED NCT06328985 Intermittent Oro-esophageal Tube Feeding in Traumatic Brain Injury Patients COMPLETED NCT05036707 Human Immune Response to Ixodes Scapularis Tick Bites RECRUITING NCT01536782 Optimal Tube Feeding Method in Head and Neck Cancer Patients WITHDRAWN

Other Devices by Envizion Medical , Ltd.

K191387ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube K203133ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube

Related Devices (Code: KNT)

K163092TubeClear Control Box and Clearing StemActuated Medical, Inc. K162110CORGRIP NG/NI Tube Retention SystemCorpak Medsystems, Inc. A Division of Haylard Health K160787Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with StyletSyncro Medical Innovations, Inc. K152246Aquarius Stoma Measuring DeviceDegania Silicone , Ltd. K153506Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management KitConsure Medical Pvt , Ltd. K160654GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)Covidien, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑