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FDA 510(k)

Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform

K-Number: K181389 · 2018-06-19

ApplicantCovidien
Decision Date2018-06-19
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2018-06-19 under approval number K181389. 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 FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform?

Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform is a medical device that received FDA 510(k) clearance on 2018-06-19. It is manufactured by Covidien. The 510(k) number is K181389.

When was Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform approved by the FDA?

Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform received FDA 510(k) clearance on 2018-06-19, under approval number K181389.

What company makes Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform?

Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform is manufactured by Covidien.

What is the FDA product code for Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform?

The FDA product code for Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy 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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