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510(k) K994253

Device
VACLOK SYRINGE
Applicant
MERIT MEDICAL SYSTEMS, INC.
510(k) number
K994253
Product code
FMF  
Decision
Substantially Equivalent (SESE)
Decision date
2000-01-05
Date received
1999-12-17
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
CHESTER MCCOY
Address
1600 W. Merit Pkwy. South Jordan UT US 84095 84095

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
K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.2026-08-14
K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC2026-07-13
K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.2026-06-18
K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.2026-06-12
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

Legacy Summary#

summary

FDA Review#

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