Cleared Traditional

K201395 - Sterile High-pressure Angiographic Syringes for single-use

K201395 is an FDA 510(k) clearance for Sterile High-pressure Angiographic Syri..., manufactured by Youwo (Guangzhou) Medical Device Co., Ltd.. The device is a Class 2 General Hospital device with product code DXT cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K201395 · Youwo (Guangzhou) Medical Device Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
154d
Days
Class 2
Risk

K201395 is an FDA 510(k) clearance for the Sterile High-pressure Angiographic Syringes for single-use. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Youwo (Guangzhou) Medical Device Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on October 28, 2020 after a review of 154 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 870.1650 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K201395

510(k) Number K201395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2020
Decision Date October 28, 2020
Days to Decision 154 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 129d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 General Hospital devices follow this clearance model.

Regulatory Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

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.

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All 210
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K201395 · Sterile High-pressure Angiographic Syringes for single-use
Download PDF FDA Summary Youwo (Guangzhou) Med…