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FDA 510(k)

Valleylab FX8 Electrosurgical Platform

K-Number: K172757 · 2017-11-02

ApplicantCovidien, LLC
Decision Date2017-11-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Valleylab FX8 Electrosurgical Platform is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2017-11-02 under approval number K172757. 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 Valleylab FX8 Electrosurgical Platform?

Valleylab FX8 Electrosurgical Platform is a medical device that received FDA 510(k) clearance on 2017-11-02. It is manufactured by Covidien, LLC. The 510(k) number is K172757.

When was Valleylab FX8 Electrosurgical Platform approved by the FDA?

Valleylab FX8 Electrosurgical Platform received FDA 510(k) clearance on 2017-11-02, under approval number K172757.

What company makes Valleylab FX8 Electrosurgical Platform?

Valleylab FX8 Electrosurgical Platform is manufactured by Covidien, LLC.

What is the FDA product code for Valleylab FX8 Electrosurgical Platform?

The FDA product code for Valleylab FX8 Electrosurgical Platform 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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