FDA.reportPublic FDA data

510(k) K210848

Device
Sure-Fine Insulin Syringes
Applicant
Shina Med Corporation
510(k) number
K210848
Product code
FMF
Decision
Substantially Equivalent (SESE)
Decision date
2022-03-01
Date received
2021-03-22
Regulation
880.5860
Classification name
Syringe, Piston
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jeong Ho Ryu
Address
455-30, Bogaewonsam-Ro, Bogae-Myeon Anseong-Si KR 17509 17509

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FMF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.2026-05-21
K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.2026-04-17
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K250192Verisafe Safety Retractable Insulin SyringesPromisemed Hangzhou Meditech Co., Ltd.2025-12-10
K250853Merit SyringeMerit Medical Systems, Inc.2025-11-04
K250510Sure-Fine Insulin SyringesShina Med Corporation2025-10-15
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K251350BD Plastipak™ SyringeBecton, Dickinson and Company2025-07-29
K252033Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with NeedleCMT Health PTE., Ltd.2025-07-25
K2507333DOSE 1ml SyringeBimed Teknik Aletler Sanayi & Ticaret A.S.2025-07-03
K251648GPS Advanced; GPS Advanced CannulaProsidyan, Inc.2025-06-24
K250262GO-PEN®Go-Pen Aps2025-04-24