Cleared Special

K213356 - Entuit PEG, Entuit PEGJ (FDA 510(k) Clearance)

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

K213356 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 49
Devices cleared under the same product code (PIF) and FDA review panel - the closest regulatory comparables to K213356.
Percutaneous Endoscopic Gastrostomy (PEG) Kit
K254170 · Degania Silicone , Ltd. · Mar 2026
Enteral Drainage System, Enteral Medicine straw
K242917 · Hmc Premedical S.P.A. · Jun 2025
Extension Feeding Set with ENFit™ Connectors
K250481 · SKY Medical, a.s. · Apr 2025
Disposable Enteral Feeding Sets
K240052 · Beijing L&Z Medical Technology Development Co., Ltd. · Jul 2024
Mobility+ Enteral Feeding System OTC
K233034 · Rockfield Medical · Apr 2024
Feeding Tube
K222773 · Anhui Tiankang Medical Technology Co., Ltd. · Aug 2023