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FDA 510(k)

BD U-500 INSULIN SYRINGE

K-Number: K151870 · 2016-07-08

ApplicantBecton, Dickinson and Company
Decision Date2016-07-08
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD U-500 INSULIN SYRINGE is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2016-07-08 under approval number K151870. 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 U-500 INSULIN SYRINGE?

BD U-500 INSULIN SYRINGE is a medical device that received FDA 510(k) clearance on 2016-07-08. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K151870.

When was BD U-500 INSULIN SYRINGE approved by the FDA?

BD U-500 INSULIN SYRINGE received FDA 510(k) clearance on 2016-07-08, under approval number K151870.

What company makes BD U-500 INSULIN SYRINGE?

BD U-500 INSULIN SYRINGE is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD U-500 INSULIN SYRINGE?

The FDA product code for BD U-500 INSULIN SYRINGE is FMF.

Related Clinical Trials

NCT02812927 Evaluation of Glycemic Variability (GLAIVE) COMPLETED

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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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