Cleared Traditional

K220063 - Single Use Cytology Brush (FDA 510(k) Clearance)

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

K220063 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Gastroenterology & Urology device
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Jul 2022
Decision
199d
Days
Class 2
Risk

K220063 is an FDA 510(k) clearance for the Single Use Cytology Brush. Classified as Endoscopic Cytology Brush (product code FDX), Class II - Special Controls.

Submitted by Zhejiang Chuangxiang Medical Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on July 28, 2022 after a review of 199 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 Zhejiang Chuangxiang Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K220063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2022
Decision Date July 28, 2022
Days to Decision 199 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 130d · This submission: 199d
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.