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FDA 510(k)

Valleylab FT10 Electrosurgical Platform

K-Number: K191601 · 2019-07-12

ApplicantCovidien
Decision Date2019-07-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Valleylab FT10 Electrosurgical Platform is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2019-07-12 under approval number K191601. 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 Electrosurgical Platform?

Valleylab FT10 Electrosurgical Platform is a medical device that received FDA 510(k) clearance on 2019-07-12. It is manufactured by Covidien. The 510(k) number is K191601.

When was Valleylab FT10 Electrosurgical Platform approved by the FDA?

Valleylab FT10 Electrosurgical Platform received FDA 510(k) clearance on 2019-07-12, under approval number K191601.

What company makes Valleylab FT10 Electrosurgical Platform?

Valleylab FT10 Electrosurgical Platform is manufactured by Covidien.

What is the FDA product code for Valleylab FT10 Electrosurgical Platform?

The FDA product code for Valleylab FT10 Electrosurgical Platform is GEI.

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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.