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FDA 510(k)

BD SoloShot Mini Syringe/ BD Auto Disable Syringe

K-Number: K201234 · 2020-07-15

ApplicantBecton, Dickinson and Company
Decision Date2020-07-15
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD SoloShot Mini Syringe/ BD Auto Disable Syringe is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2020-07-15 under approval number K201234. 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 SoloShot Mini Syringe/ BD Auto Disable Syringe?

BD SoloShot Mini Syringe/ BD Auto Disable Syringe is a medical device that received FDA 510(k) clearance on 2020-07-15. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K201234.

When was BD SoloShot Mini Syringe/ BD Auto Disable Syringe approved by the FDA?

BD SoloShot Mini Syringe/ BD Auto Disable Syringe received FDA 510(k) clearance on 2020-07-15, under approval number K201234.

What company makes BD SoloShot Mini Syringe/ BD Auto Disable Syringe?

BD SoloShot Mini Syringe/ BD Auto Disable Syringe is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD SoloShot Mini Syringe/ BD Auto Disable Syringe?

The FDA product code for BD SoloShot Mini Syringe/ BD Auto Disable Syringe is FMF.

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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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