Cleared Traditional

ENvizion Medical ENvue (K182915) - FDA 510(k) Clearance

Also marketed or referenced as:
ENvizion Medical Enteral Feeding Tube

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence.

K182915 · Envizion Medical , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
118d
Days
Class 2
Risk

K182915 is an FDA 510(k) clearance for the ENvizion Medical ENvue. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Envizion Medical , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on February 13, 2019 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Envizion Medical , Ltd. devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 130d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Shriner & Associates
Clay Anselmo

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT03371160 Terminated Interventional Industry-sponsored

Feasibility Study to Evaluate Safety of Nutriseal™ Nutriplace™ System

A Feasibility Study to Evaluate the Clinical Safety of Nutriseal™ Enteral Feeding Tube Placement Using the Nutriseal™ Nutriplace™ System in Patients

22
Patients (actual)
1
Site
Supportive_care
Purpose
Open label
Masking
Condition studied Enteral Nutrition
Study design Single group
Eligibility All sexes · 21 Years+
Principal investigator May Olayan, MD
Sponsor Nutriseal L.P (industry)
Started 2017-12-13 → Primary completion 2018-03-15
Primary outcome
Number of Participants With Successfully Placed Enteral Feeding Tube
Secondary outcome
Number of Participants Requiring Replacement and/or Repositioning of the Feeding Tube
View full study on ClinicalTrials.gov

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 142
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K182915.
Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
K190114 · Convatec Limited · Apr 2019
Micro Transgastric-Jejunal Feeding Device
K183508 · Applied Medical Technology, Inc. · Mar 2019
Traditional Length GJ Feeding Device
K182804 · Applied Medical Technology, Inc. · Mar 2019
Aspire Venting Tube
K182248 · Aspire Bariatrics, Inc. · Nov 2018
GastroFlush
K180605 · Bionix Development Corporation · Oct 2018
Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port
K180622 · Covidien · Oct 2018