Cleared Special

K151889 - Infinity ERCP Sampling Device

K151889 is an FDA 510(k) clearance for Infinity ERCP Sampling Device, manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDX cleared through the Special 510(k) pathway after a 20-day FDA review.

K151889 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Jul 2015
Decision
20d
Days
Class 2
Risk

K151889 is an FDA 510(k) clearance for the Infinity ERCP Sampling Device. Classified as Endoscopic Cytology Brush (product code FDX), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on July 30, 2015 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 United States Endoscopy Group, Inc. devices

FDA 510(k) Submission Details - K151889

510(k) Number K151889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2015
Decision Date July 30, 2015
Days to Decision 20 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 131d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

FDX Device Classification - Class 2, Special Controls

Product Code FDX Endoscopic Cytology Brush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Collect Cells For Cytological Evaluation.
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 - FDX Endoscopic Cytology Brush

All 36
Devices cleared under the same product code (FDX) and FDA review panel - the closest regulatory comparables to K151889.
Cytology Brush
K172663 · Micro-Tech (Nanjing) Co., Ltd. · Mar 2018
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
K171573 · Wilson-Cook Medical, Inc. · Dec 2017
Bronchi and Gastrointestinal Cytology Brush
K171607 · Wilson-Cook Medical Inc./Cook Endoscopy · Jul 2017
US ENDOSCOPY CYTOLOGY BRUSH
K103437 · United States Endoscopy Group, Inc. · Dec 2010
COOK IRELAND ECHOBRUSH
K052279 · Cook Ireland, Ltd. · Oct 2005
WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
K040324 · Wilson-Cook Medical, Inc. · May 2004