FDA.report

510(k) K253769

Device
Instylla Delivery Kit
Applicant
Instylla, Inc.
510(k) number
K253769
Product code
FMF
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-22
Date received
2025-11-25
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Jennifer Greer
Address
201 Burlington Rd. North Bldg. Bedford MA US 01730 01730

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code FMF

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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
K243580GraftGun Universal Graft Delivery System (GDS)SurGenTec, LLC2025-02-05
K242434Insulin SyringesChirana T. Injecta2024-12-24