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FDA 510(k)

Plasma Edge System

K-Number: K163090 · 2017-05-23

ApplicantChirurgie Innovation
Decision Date2017-05-23
Product CodeFAS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Plasma Edge System is a medical device manufactured by Chirurgie Innovation. It received FDA 510(k) clearance on 2017-05-23 under approval number K163090. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Plasma Edge System?

Plasma Edge System is a medical device that received FDA 510(k) clearance on 2017-05-23. It is manufactured by Chirurgie Innovation. The 510(k) number is K163090.

When was Plasma Edge System approved by the FDA?

Plasma Edge System received FDA 510(k) clearance on 2017-05-23, under approval number K163090.

What company makes Plasma Edge System?

Plasma Edge System is manufactured by Chirurgie Innovation.

What is the FDA product code for Plasma Edge System?

The FDA product code for Plasma Edge System is FAS.

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Other Devices by Chirurgie Innovation

K213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge

Related Devices (Code: FAS)

K151976Omnitech HF Resection Electrodes, Omnitech HF Vaporization ElectrodeOmnitech Systems, Inc. K171965Resection Electrodes with HF cableOlympus Winter & Ibe GmbH K210651Resection Electrodes with HF cableOlympus Winter & Ibe GmbH K210394Electrosurgical accessoryDornier Medtech America, Inc. K213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma EdgeChirurgie Innovation K240504PLASMA EDGE SystemLamidey Noury Medical

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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