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FDA 510(k)

Edge Insulated Blade Electrode

K-Number: K210338 · 2021-04-15

ApplicantCovidien, LLC
Decision Date2021-04-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Edge Insulated Blade Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2021-04-15 under 510(k) 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. The listed applicant is Covidien, LLC. The 510(k) number is K210338.

When did Edge Insulated Blade Electrode receive FDA 510(k) clearance?

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

Who is the listed applicant for Edge Insulated Blade Electrode?

The FDA 510(k) record lists Covidien, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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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