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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 the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2019-07-12 under 510(k) 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. The listed applicant is Covidien. The 510(k) number is K191601.

When did Valleylab FT10 Electrosurgical Platform receive FDA 510(k) clearance?

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

Who is the listed applicant for Valleylab FT10 Electrosurgical 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 Electrosurgical Platform?

The FDA product code for Valleylab FT10 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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