Cleared Traditional

K243175 - Disposable Intermittent Catheter (TPU C...

K243175 is an FDA 510(k) clearance for Disposable Intermittent Catheter (TPU C..., manufactured by Chengdu Daxan Innovative Medical Tech. Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K243175 · Chengdu Daxan Innovative Medical Tech. Co., Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jun 2025
Decision
269d
Days
Class 2
Risk

K243175 is an FDA 510(k) clearance for the Disposable Intermittent Catheter (TPU Catheter). Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Chengdu Daxan Innovative Medical Tech. Co., Ltd. (Chengdu, CN). The FDA issued a Cleared decision on June 26, 2025 after a review of 269 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Chengdu Daxan Innovative Medical Tech. Co., Ltd. devices

FDA 510(k) Submission Details - K243175

510(k) Number K243175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date June 26, 2025
Days to Decision 269 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
139d slower than avg
Panel avg: 130d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZD Device Classification - Class 2, Special Controls

Product Code EZD Catheter, Straight
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 Consultant

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Boyle Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.