Cleared Traditional

Deflectable Brush Biopsy Set

K191485 · Cook Incorporated · Gastroenterology & Urology

Jun 2019

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K191485 is an FDA 510(k) clearance for the Deflectable Brush Biopsy Set, a Endoscopic Cytology Brush (Class II — Special Controls, product code FDX), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on June 26, 2019, 22 days after receiving the submission on June 4, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K191485 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 2019
Decision Date	June 26, 2019
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

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.