Cleared Special

K171347 - Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection (FDA 510(k) Clearance)

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

K171347 · Xeridiem Medical Devices · Gastroenterology & Urology device
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Jun 2017
Decision
29d
Days
Class 2
Risk

K171347 is an FDA 510(k) clearance for the Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Ent.... Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Xeridiem Medical Devices (Tucson, US). The FDA issued a Cleared decision on June 6, 2017 after a review of 29 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 Xeridiem Medical Devices devices

Submission Details

510(k) Number K171347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2017
Decision Date June 06, 2017
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 130d · This submission: 29d
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 K171347.
Percutaneous Endoscopic Gastrostomy (PEG) Kit
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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
ENFit to ENFit Extension Sets
K230326 · Vesco Medical · Nov 2023