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

FDA 510(k)

ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube

K-Number: K191387 · 2019-06-14

ApplicantEnvizion Medical , Ltd.
Decision Date2019-06-14
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube is the device name listed in this FDA 510(k) record. The listed applicant is Envizion Medical , Ltd.. It received FDA 510(k) clearance on 2019-06-14 under 510(k) number K191387. 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 SYSTEM, ENvizion Medical Enteral Feeding Tube?

ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube is a medical device that received FDA 510(k) clearance on 2019-06-14. The listed applicant is Envizion Medical , Ltd.. The 510(k) number is K191387.

When did ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube receive FDA 510(k) clearance?

ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube received FDA 510(k) clearance on 2019-06-14, under 510(k) number K191387.

Who is the listed applicant for ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube?

The FDA 510(k) record lists Envizion Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube?

The FDA product code for ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube is KNT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT01536782Optimal Tube Feeding Method in Head and Neck Cancer PatientsWITHDRAWNNCT06328894Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke PatientsCOMPLETEDNCT06328985Intermittent Oro-esophageal Tube Feeding in Traumatic Brain Injury PatientsCOMPLETEDNCT06691893Evaluating the Efficacy of RELiZORB in Managing Exocrine Pancreatic Insufficiency in Tube-fed Pancreatitis PatientsRECRUITING

Other records listing Envizion Medical , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203133ENvizion Medical ENvue ENvizion Medical Enteral Feeding TubeK182915ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube

Related Devices (Code: KNT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLCK253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)C.R. Bard, Inc.K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,LtdK243228Flexi-Seal AIR (with ENFit Connector)ConvatecK242336hygh-tec Drainage IIAmb MedtecK242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)Tools For Surgery, 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.

↑