FDA.reportPublic FDA data

510(k) K201284

Device
Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use
Applicant
Set Medikal Sanayi VE Ticaret Anonim Sirketi
510(k) number
K201284
Product code
FMF
Decision
Substantially Equivalent (SESE)
Decision date
2020-12-14
Date received
2020-05-13
Regulation
880.5860
Classification name
Syringe, Piston
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Mehice Ozturk
Address
Osmangazi Mahallesi Maresal Fevzi Cakmak Caddesi #18 Esenyurt Istanbul TR 34522 34522

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
K253068Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin SyringeCMT Health PTE., Ltd.2026-02-23
K253769Instylla Delivery KitInstylla, Inc.2025-12-22
K252518DuoprossTM Smart Cap (Type I)Duopross Meditech Corporate2025-12-17
K251089EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic NeedleExelint International, Co.2025-12-12
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
K243660Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); MonojecCardinalhealth2025-08-22
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