Cleared Special

Infinity ERCP Sampling Device

K151889 · United States Endoscopy Group, Inc. · Gastroenterology & Urology

Jul 2015

Decision

20d

Days

Class 2

Risk

About This 510(k) Submission

K151889 is an FDA 510(k) clearance for the Infinity ERCP Sampling Device, a Endoscopic Cytology Brush (Class II — Special Controls, product code FDX), submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on July 30, 2015, 20 days after receiving the submission on July 10, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K151889 FDA.gov
FDA Decision	Cleared 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

Device Classification

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