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FDA 510(k)

Freedom Syringe

K-Number: K161812 · 2017-03-27

ApplicantProcedure Products, Inc.
Decision Date2017-03-27
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Freedom Syringe is a medical device manufactured by Procedure Products, Inc.. It received FDA 510(k) clearance on 2017-03-27 under approval number K161812. 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 Freedom Syringe?

Freedom Syringe is a medical device that received FDA 510(k) clearance on 2017-03-27. It is manufactured by Procedure Products, Inc.. The 510(k) number is K161812.

When was Freedom Syringe approved by the FDA?

Freedom Syringe received FDA 510(k) clearance on 2017-03-27, under approval number K161812.

What company makes Freedom Syringe?

Freedom Syringe is manufactured by Procedure Products, Inc..

What is the FDA product code for Freedom Syringe?

The FDA product code for Freedom Syringe is FMF.

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

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

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