Cleared Special

ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube (K191387) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K191387 · Envizion Medical , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
21d
Days
Class 2
Risk

K191387 is an FDA 510(k) clearance for the ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube. 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 June 14, 2019 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Envizion Medical , Ltd. devices

Submission Details

510(k) Number K191387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2019
Decision Date June 14, 2019
Days to Decision 21 days
Submission Type Special
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
109d faster than avg
Panel avg: 130d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. 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.

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 K191387.
Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches
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Navina Smart System, Navina Classic System
K190977 · Dentsply Sirona · Nov 2019
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CORTRAK* 2 Equilateral Enteral Access System
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Entuit PEG, Entuit PEGJ
K183336 · Wilson-Cook Medical, Inc. · May 2019
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K183577 · Medline Industries, Inc. · May 2019