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510(k) K213135

Device
Plasma Edge Resection And Vaporization Electrodes, Plasma Edge Working Elements, Adaptor Plasma Edge
Applicant
Chirurgie Innovation
510(k) number
K213135
Product code
FAS  
Decision
Substantially Equivalent (SESE)
Decision date
2022-03-02
Date received
2021-09-27
Regulation
876.4300
Classification name
Electrode, Electrosurgical, Active, Urological
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Guillaume Noury
Address
Z.A Les Godets, 3 Rue Des Petits Ruisseaux Verrières Le Buisson FR 91370 91370

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FAS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251403Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc )Dornier Medtech America Inc (Dmta)2025-12-05
K250522Multi4 SystemMulti4 Medical AB2025-06-27
K240504PLASMA EDGE SystemLamidey Noury Medical2024-06-12
K210651Resection Electrodes with HF cableOlympus Winter & Ibe GmbH2021-08-03
K210394Electrosurgical accessoryDornier Medtech America, Inc.2021-05-19
K171965Resection Electrodes with HF cableOlympus Winter & Ibe GmbH2017-09-28
K163090Plasma Edge SystemChirurgie Innovation2017-05-23
K151976Omnitech HF Resection Electrodes, Omnitech HF Vaporization ElectrodeOmnitech Systems, Inc.2016-06-27
K152092Resection ElectrodesOlympus Winter & Ibe GmbH2015-10-26
K120418ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIESOlympus Winter & Ibe GmbH2012-06-20
K120567GYRUS AMCI PK BUTTON ELECTRODEGyrus Acmi, Inc.2012-06-20
K102781RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDSOlympus Winter & Ibe GmbH2011-01-11
K100275WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDSOlympus Winter & Ibe GmbH2010-07-01
K093181GYRUS ACMI PK BUTTON ELECTRODEGyrus Acmi, Inc.2010-02-24
K091511MODERN MEDICAL RESECTOSCOPE ELECTRODESModern Medical Equipment Mfg., Ltd.2010-01-15

Legacy Summary#

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FDA Review#

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