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FDA 510(k)

PlasmaBlade X 3.0S LIGHT

K-Number: K193579 · 2020-03-24

Decision Date2020-03-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PlasmaBlade X 3.0S LIGHT is a medical device manufactured by Medtronic Navigation. It received FDA 510(k) clearance on 2020-03-24 under approval number K193579. 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 PlasmaBlade X 3.0S LIGHT?

PlasmaBlade X 3.0S LIGHT is a medical device that received FDA 510(k) clearance on 2020-03-24. It is manufactured by Medtronic Navigation. The 510(k) number is K193579.

When was PlasmaBlade X 3.0S LIGHT approved by the FDA?

PlasmaBlade X 3.0S LIGHT received FDA 510(k) clearance on 2020-03-24, under approval number K193579.

What company makes PlasmaBlade X 3.0S LIGHT?

PlasmaBlade X 3.0S LIGHT is manufactured by Medtronic Navigation.

What is the FDA product code for PlasmaBlade X 3.0S LIGHT?

The FDA product code for PlasmaBlade X 3.0S LIGHT is GEI.

Other Devices by Medtronic Navigation

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Related Devices (Code: GEI)

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.