Cleared Traditional

Valleylab ?FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)

K241085 · Covidien, LLC · General & Plastic Surgery
Jul 2024
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K241085 is an FDA 510(k) clearance for the Valleylab ?FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN), a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Covidien, LLC (Lafayette, US). The FDA issued a Cleared decision on July 12, 2024, 84 days after receiving the submission on April 19, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K241085 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2024
Decision Date July 12, 2024
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).

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