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FDA 510(k)

BD Insulin Syringe

K-Number: K190054 · 2019-10-21

ApplicantBecton, Dickinson and Company
Decision Date2019-10-21
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Insulin Syringe is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2019-10-21 under approval number K190054. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Insulin Syringe?

BD Insulin Syringe is a medical device that received FDA 510(k) clearance on 2019-10-21. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K190054.

When was BD Insulin Syringe approved by the FDA?

BD Insulin Syringe received FDA 510(k) clearance on 2019-10-21, under approval number K190054.

What company makes BD Insulin Syringe?

BD Insulin Syringe is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD Insulin Syringe?

The FDA product code for BD Insulin Syringe is FMF.

Related Clinical Trials

NCT02812927 Evaluation of Glycemic Variability (GLAIVE) COMPLETED

Other Devices by Becton, Dickinson and Company

K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe K162516BD Pen Needle K160657BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube K151589BD MAX CT/GC/TV, BD MAX INSTRUMENT K151870BD U-500 INSULIN SYRINGE K161553BD SafeAssist

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Related Devices (Code: FMF)

K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd. K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeBecton, Dickinson and Company K162602NovoPen EchoNovo Nordisk, Inc. K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. K152879Sure-Fine Insulin SyringesShina Med Corporation K160629InPenCompanion Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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