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510(k) K190183

Device
Hypodermic Safety Needle, Hypodermic Safety Needle With Syringe
Applicant
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
510(k) number
K190183
Product code
MEG  
Decision
Substantially Equivalent (SESE)
Decision date
2019-10-04
Date received
2019-02-01
Regulation
880.5860
Classification name
Syringe, Antistick
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gang Yu
Address
# 2 Guanyin Rd., Economic Development Zone Taihu, Anqing City CN 246400 246400

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MEG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd.2026-02-18
K250847VaporShieldVault Paragon Group, Inc.2025-12-12
K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd.2023-11-21
K231165Shina Syringe; Shina Safety SyringeShina Med Corporation2023-10-27
K231907Medline Safety Insulin and TB SyringesMedline Industries, LP2023-10-18
K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC2023-06-21
K220114PowerPAK SyringeVault Paragon Group, Inc.2023-01-25
K221981SafeR Syringe and SafeR StingRoncadelle Operations Srl2022-12-29
K222452Disposable Automatically Retractable Safety Syringes (with detachable needle)Shantou Wealy Medical Instrument Co.,Ltd2022-11-23
K221247Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable NeedleJiangsu Kangbao Medical Equipment Co., Ltd.2022-11-01
K220057Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose ImmunizationShinva Ande Healthcare Apparatus Co., Ltd.2022-10-07
K221073Sterile Hypodermic Syringes for Single Use with Safety NeedlesSichuan Prius Biotechnology Co., Ltd.2022-10-04
K220061Safety Insulin SyringesBerpu Medical Technology Co., Ltd.2022-08-23
K212518Jeesung Safety Syringe and Single Use NeedlesJeesung Medical Co., Ltd.2022-08-18
K213077Automatically Retractable Safety SyringeZhejiang Lingyang Medical Apparatus Co., Ltd.2022-04-27

Legacy Summary#

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FDA Review#

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