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510(k) K974637

Device
ELECTRODES/PROBES/DEVICES
Applicant
XIMED/PROSURE/INJECTX
510(k) number
K974637
Product code
FAS  
Decision
Substantially Equivalent (SESE)
Decision date
1998-01-07
Date received
1997-12-12
Regulation
876.4300
Classification name
Electrode, Electrosurgical, Active, Urological
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ASHVIN DESAI
Address
2195 Trade Zone Blvd. San Jose CA US 95131 95131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma EdgeChirurgie Innovation2022-03-02
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

Legacy Summary#

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FDA Review#

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