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FDA 510(k)

Cool-tip RF Ablation System E Series

K-Number: K203150 · 2022-02-25

ApplicantCovidien, LLC
Decision Date2022-02-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cool-tip RF Ablation System E Series is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2022-02-25 under 510(k) number K203150. 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 Cool-tip RF Ablation System E Series?

Cool-tip RF Ablation System E Series is a medical device that received FDA 510(k) clearance on 2022-02-25. The listed applicant is Covidien, LLC. The 510(k) number is K203150.

When did Cool-tip RF Ablation System E Series receive FDA 510(k) clearance?

Cool-tip RF Ablation System E Series received FDA 510(k) clearance on 2022-02-25, under 510(k) number K203150.

Who is the listed applicant for Cool-tip RF Ablation System E Series?

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 Cool-tip RF Ablation System E Series?

The FDA product code for Cool-tip RF Ablation System E Series is GEI.

Other records listing Covidien, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 119 devices →

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.