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FDA 510(k)

i-ED COIL

K-Number: K192068 · 2020-04-25

ApplicantKaneka Pharma America, LLC
Decision Date2020-04-25
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

i-ED COIL is a medical device manufactured by Kaneka Pharma America, LLC. It received FDA 510(k) clearance on 2020-04-25 under approval number K192068. 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?

i-ED COIL is a medical device that received FDA 510(k) clearance on 2020-04-25. It is manufactured by Kaneka Pharma America, LLC. The 510(k) number is K192068.

When was i-ED COIL approved by the FDA?

i-ED COIL received FDA 510(k) clearance on 2020-04-25, under approval number K192068.

What company makes i-ED COIL?

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

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

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

Other Devices by Kaneka Pharma America, LLC

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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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