FDA 510(k)

Edge Insulated Blade Electrode

K-Number: K210338 · 2021-04-15

Decision Date2021-04-15

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Edge Insulated Blade Electrode is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2021-04-15 under approval number K210338. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Edge Insulated Blade Electrode?

Edge Insulated Blade Electrode is a medical device that received FDA 510(k) clearance on 2021-04-15. It is manufactured by Covidien, LLC. The 510(k) number is K210338.

When was Edge Insulated Blade Electrode approved by the FDA?

Edge Insulated Blade Electrode received FDA 510(k) clearance on 2021-04-15, under approval number K210338.

What company makes Edge Insulated Blade Electrode?

Edge Insulated Blade Electrode is manufactured by Covidien, LLC.

What is the FDA product code for Edge Insulated Blade Electrode?

The FDA product code for Edge Insulated Blade Electrode is GEI.

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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.