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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 the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2018-06-19 under 510(k) 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. The listed applicant is Covidien. The 510(k) number is K181389.

When did Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform receive FDA 510(k) clearance?

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

Who is the listed applicant for Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform?

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

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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