Cleared Traditional

Extension tube

K251788 · Zhuhai DR Medical Instruments Co., Ltd. · General Hospital

Mar 2026

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K251788 is an FDA 510(k) clearance for the Extension tube, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Zhuhai DR Medical Instruments Co., Ltd. (Zhuhai, CN). The FDA issued a Cleared decision on March 5, 2026, 267 days after receiving the submission on June 11, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number	K251788 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 11, 2025
Decision Date	March 05, 2026
Days to Decision	267 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF