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510(k) K213077

Automatically Retractable Safety Syringe by Zhejiang Lingyang Medical Apparatus Co., Ltd. — Product Code MEG

K213077 is an FDA 510(k) premarket notification submitted by Zhejiang Lingyang Medical Apparatus Co., Ltd. for the device "Automatically Retractable Safety Syringe". The FDA issued a decision of Substantially Equivalent on April 27, 2022. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2022
Date Received
September 23, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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FDA data resources