Cleared Traditional

ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube (K203133) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203133 · Envizion Medical , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2021
Decision
156d
Days
Class 2
Risk

K203133 is an FDA 510(k) clearance for the ENvizion Medical ENvue 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 March 24, 2021 after a review of 156 days - an extended review cycle.

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 K203133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2020
Decision Date March 24, 2021
Days to Decision 156 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
26d slower than avg
Panel avg: 130d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Evergreen Research, Inc.
John Mann

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 K203133.
Standard Bougie, 38 Fr.
K210437 · Standard Bariatrics · Jun 2021
Safety Trocar Cannula
K211072 · Boston Scientific Corporation · Apr 2021
Enteral Feeding Catheter
K202748 · Medcaptain Life Science Co., Ltd. · Apr 2021
TubeClear System
K200646 · Actuated Medical, Inc. · Dec 2020
Nutriglide(TM) Nasal Feeding Tube
K202539 · Applied Medical Technology, Inc. · Oct 2020
Entuit Nasal Jejunal Feeding Tube
K201322 · Wilson-Cook Medical, Inc. · Jun 2020