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FDA 510(k)

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

K-Number: K213135 · 2022-03-02

ApplicantChirurgie Innovation
Decision Date2022-03-02
Product CodeFAS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge is a medical device manufactured by Chirurgie Innovation. It received FDA 510(k) clearance on 2022-03-02 under approval number K213135. 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 resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge?

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge is a medical device that received FDA 510(k) clearance on 2022-03-02. It is manufactured by Chirurgie Innovation. The 510(k) number is K213135.

When was Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge approved by the FDA?

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge received FDA 510(k) clearance on 2022-03-02, under approval number K213135.

What company makes Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge?

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge is manufactured by Chirurgie Innovation.

What is the FDA product code for Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge?

The FDA product code for Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge is FAS.

Related Clinical Trials

NCT06252532 Causal Role of Top-Down Theta Oscillations in Prioritization ENROLLING_BY_INVITATION NCT06368310 FIH Clinical Investigation of Graphene Electrodes for Brain Mapping RECRUITING

Other Devices by Chirurgie Innovation

K163090Plasma Edge System

Related Devices (Code: FAS)

K151976Omnitech HF Resection Electrodes, Omnitech HF Vaporization ElectrodeOmnitech Systems, Inc. K171965Resection Electrodes with HF cableOlympus Winter & Ibe GmbH K163090Plasma Edge SystemChirurgie Innovation K210651Resection Electrodes with HF cableOlympus Winter & Ibe GmbH K210394Electrosurgical accessoryDornier Medtech America, Inc. 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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