510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K201395Substantially Equivalent

Sterile High-pressure Angiographic Syringes for single-use

Youwo (Guangzhou) Medical Device Co., Ltd., Guangzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201395 is the FDA 510(k) clearance record for Sterile High-pressure Angiographic Syringes for single-use, a class II device, cleared for Youwo (Guangzhou) Medical Device Co., Ltd. on under FDA product code DXT (Injector And Syringe, Angiographic). FDA records list one 510(k) clearance for Youwo (Guangzhou) Medical Device Co., Ltd. As of , FDA records show no recalls naming K201395.

Clearance record

Decision date
Received
(154 days to decision)
Product code
DXT Injector And Syringe, Angiographic
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Youwo (Guangzhou) Medical Device Co., Ltd. Kaiyuan Ave., High-Tech Industrial Development Zone, Guangzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXT

Trailing 12 months
6 clearances under product code DXT in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DXT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20261
May 20263
June 20260
July 20260
August 20260
September 20260
October 20260