Cleared Traditional

K201395 - Sterile High-pressure Angiographic Syri...

K201395 is the FDA 510(k) clearance for Sterile High-pressure Angiographic Syri... by Youwo (Guangzhou) Medical Device Co., Ltd.. It is a Class 2 General Hospital device (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
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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.

View all Youwo (Guangzhou) Medical Device Co., Ltd. devices

Submission Details

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.

Device Classification

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.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 101
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