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FDA 510(k)

EchoGlo Needle

K-Number: K171968 · 2018-01-25

Decision Date2018-01-25
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EchoGlo Needle is a medical device manufactured by Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2018-01-25 under approval number K171968. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EchoGlo Needle?

EchoGlo Needle is a medical device that received FDA 510(k) clearance on 2018-01-25. It is manufactured by Smiths Medical Asd, Inc.. The 510(k) number is K171968.

When was EchoGlo Needle approved by the FDA?

EchoGlo Needle received FDA 510(k) clearance on 2018-01-25, under approval number K171968.

What company makes EchoGlo Needle?

EchoGlo Needle is manufactured by Smiths Medical Asd, Inc..

What is the FDA product code for EchoGlo Needle?

The FDA product code for EchoGlo Needle is BSP.

Other Devices by Smiths Medical Asd, Inc.

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Related Devices (Code: BSP)

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.