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FDA 510(k)

BD Hypodermic Syringe

K-Number: K203453 · 2021-01-25

ApplicantBecton, Dickinson and Company
Decision Date2021-01-25
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Hypodermic Syringe is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2021-01-25 under approval number K203453. 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 Hypodermic Syringe?

BD Hypodermic Syringe is a medical device that received FDA 510(k) clearance on 2021-01-25. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K203453.

When was BD Hypodermic Syringe approved by the FDA?

BD Hypodermic Syringe received FDA 510(k) clearance on 2021-01-25, under approval number K203453.

What company makes BD Hypodermic Syringe?

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

What is the FDA product code for BD Hypodermic Syringe?

The FDA product code for BD Hypodermic Syringe is FMF.

Related PubMed Literature

PMID: 38815918 What is the MAUDE Database Telling us about 510(k) Authorization? Evaluation of Two Generations of Endovascular Arteriovenous Fistula Devices. Annals of vascular surgery (2024)

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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