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510(k) K180417

Device
Self-destruction Safety Syringes For Single Use; Sterile Hypodermic Syringes For Single Use; Sterile Hypodermic Needles For Single Use; Sterile Safety Hypodermic Needles For Single Use
Applicant
BERPU MEDICAL TECHNOLOGY CO., LTD
510(k) number
K180417
Product code
MEG  
Decision
Substantially Equivalent (SESE)
Decision date
2018-08-09
Date received
2018-02-15
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
Jundong Tan
Address
# 14 Xingji Rd., Yongxing St., Longwan District Wenzhou CN 325000 325000

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#

summary

FDA Review#

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