Cleared Traditional

K183336 - Entuit PEG

K183336 is the FDA 510(k) clearance for Entuit PEG by Wilson-Cook Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K183336 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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May 2019
Decision
177d
Days
Class 2
Risk

K183336 is an FDA 510(k) clearance for the Entuit PEG, Entuit PEGJ. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on May 29, 2019 after a review of 177 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 Wilson-Cook Medical, Inc. devices

Submission Details

510(k) Number K183336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received December 03, 2018
Decision Date May 29, 2019
Days to Decision 177 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
47d slower than avg
Panel avg: 130d · This submission: 177d
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 Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 252
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K183336.
McLean-Ring Enteral Feeding Tube Set
K190084 · Cook Incorporated · Oct 2019
ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube
K191387 · Envizion Medical , Ltd. · Jun 2019
CORTRAK* 2 Equilateral Enteral Access System
K191340 · Avanos Medical, Inc. · Jun 2019
Medline Quick-Clear Wand
K183577 · Medline Industries, Inc. · May 2019
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