Cleared Traditional

DR Safety Syringe, Sterile Hypodermic needle for Single use

K212226 · Zhuhai DR Medical Instruments Co., Ltd. · General Hospital

Sep 2021

Decision

75d

Days

Class 2

Risk

About This 510(k) Submission

K212226 is an FDA 510(k) clearance for the DR Safety Syringe, Sterile Hypodermic needle for Single use, a Syringe, Antistick (Class II — Special Controls, product code MEG), submitted by Zhuhai DR Medical Instruments Co., Ltd. (Zhuhai, CN). The FDA issued a Cleared decision on September 29, 2021, 75 days after receiving the submission on July 16, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K212226 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 16, 2021
Decision Date	September 29, 2021
Days to Decision	75 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF