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FDA 510(k)

i-ED COIL System

K-Number: K210638 · 2021-03-26

ApplicantKaneka Medical America, LLC
Decision Date2021-03-26
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

i-ED COIL System is a medical device manufactured by Kaneka Medical America, LLC. It received FDA 510(k) clearance on 2021-03-26 under approval number K210638. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the i-ED COIL System?

i-ED COIL System is a medical device that received FDA 510(k) clearance on 2021-03-26. It is manufactured by Kaneka Medical America, LLC. The 510(k) number is K210638.

When was i-ED COIL System approved by the FDA?

i-ED COIL System received FDA 510(k) clearance on 2021-03-26, under approval number K210638.

What company makes i-ED COIL System?

i-ED COIL System is manufactured by Kaneka Medical America, LLC.

What is the FDA product code for i-ED COIL System?

The FDA product code for i-ED COIL System is HCG.

Other Devices by Kaneka Medical America, LLC

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Related Devices (Code: HCG)

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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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