Cleared Special

K213356 - Entuit PEG

K213356 is the FDA 510(k) clearance for Entuit PEG by Wilson-Cook Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code PIF) cleared through the Special 510(k) pathway after a 100-day FDA review.

K213356 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Jan 2022
Decision
100d
Days
Class 2
Risk

K213356 is an FDA 510(k) clearance for the Entuit PEG, Entuit PEGJ. Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on January 20, 2022 after a review of 100 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Wilson-Cook Medical, Inc. devices

Submission Details

510(k) Number K213356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received October 12, 2021
Decision Date January 20, 2022
Days to Decision 100 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
30d faster than avg
Panel avg: 130d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PIF Gastrointestinal Tubes With Enteral Specific Connectors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
Definition To Facilitate Enteral Specific Connections.
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 - PIF Gastrointestinal Tubes With Enteral Specific Connectors

All 36
Devices cleared under the same product code (PIF) and FDA review panel - the closest regulatory comparables to K213356.
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Enteral Feeding Set
K210854 · Kb Medical (Group), Inc. · Nov 2021
Pediatric Nasogastric Feeding Tubes - Single ENFit Port
K210598 · Cair Lgl · Nov 2021
Enteral Extension Sets
K203633 · GBUK Group, Ltd. · Aug 2021