510(k) K212226

DR Safety Syringe, Sterile Hypodermic needle for Single use by Zhuhai DR Medical Instruments Co., Ltd. — Product Code MEG

K212226 is an FDA 510(k) premarket notification submitted by Zhuhai DR Medical Instruments Co., Ltd. for the device "DR Safety Syringe, Sterile Hypodermic needle for Single use". The FDA issued a decision of Substantially Equivalent on September 29, 2021. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Zhuhai DR Medical Instruments Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2021
Date Received
July 16, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Syringe, Antistick
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type