Cleared Traditional

K182231 - Brush Biopsy Set (FDA 510(k) Clearance)

Also includes:
Deflectable Brush Biopsy Set

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182231 · Cook Incorporated · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
257d
Days
Class 2
Risk

K182231 is an FDA 510(k) clearance for the Brush Biopsy Set. Classified as Endoscopic Cytology Brush (product code FDX), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on May 1, 2019 after a review of 257 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook Incorporated devices

Submission Details

510(k) Number K182231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2018
Decision Date May 01, 2019
Days to Decision 257 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 130d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 43
Devices cleared under the same product code (FDX) and FDA review panel - the closest regulatory comparables to K182231.
Single Use Cytology Brush V (BC-V600P-3010)
K250993 · Olympus Medical Systems Corporation · Dec 2025
Single Use Cytology Brush
K220063 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Jul 2022
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
K192908 · Wilson-Cook Medical, Inc. · Nov 2019
Deflectable Brush Biopsy Set
K191485 · Cook Incorporated · Jun 2019
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
K181317 · Wilson-Cook Medical, Inc. · Feb 2019