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FDA 510(k)

Arisure Dry Spike

K-Number: K172631 · 2017-09-29

ApplicantYukon Medical
Decision Date2017-09-29
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Arisure Dry Spike is a medical device manufactured by Yukon Medical. It received FDA 510(k) clearance on 2017-09-29 under approval number K172631. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arisure Dry Spike?

Arisure Dry Spike is a medical device that received FDA 510(k) clearance on 2017-09-29. It is manufactured by Yukon Medical. The 510(k) number is K172631.

When was Arisure Dry Spike approved by the FDA?

Arisure Dry Spike received FDA 510(k) clearance on 2017-09-29, under approval number K172631.

What company makes Arisure Dry Spike?

Arisure Dry Spike is manufactured by Yukon Medical.

What is the FDA product code for Arisure Dry Spike?

The FDA product code for Arisure Dry Spike is LHI.

Other Devices by Yukon Medical

K172884Arisure Closed Vial Adapter K171101Closed Male Luer

Related Devices (Code: LHI)

K161800OnSite-IVPharmc, LLC K160503Vented Vial Adapter Transfer Device - 13mmMedimop Medical Projects, Ltd. K151423APEX Compounding System Transfer SetB.Braun Medical, Inc. K162216GRI-FILL PERISTALTIC SETLaboratorios Grifols, S.A. K171796Vial Adapter 15mmMedimop Medical Project , Ltd. K172884Arisure Closed Vial AdapterYukon Medical

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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