US ENDOSCOPY CYTOLOGY BRUSH— 510(k) K103437

Clearance details

Applicant

United States Endoscopy Group, Inc.

Product code

Code FDX

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2010-11-23

Decision date

2010-12-23

Decision

Substantially Equivalent

Clearance type

Special

Location

Mentor, OH, US

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• Z-2396-2012 — Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract.Class II·Terminated·US Endoscopy Group Inc·20111222

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103437.