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Valleylab FT10 Electrosurgical Platform

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191601

by Covidien

Identifiers

510(k) Number
K191601 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Valleylab FT10 Electrosurgical Platform by Covidien — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Covidien

Sources (1)

  • FDA 510(k) K191601 24 fields · synced Jun 19, 2026