FDA.reportPublic FDA data

510(k) K151976

Device
Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode
Applicant
OMNITECH SYSTEMS, INC.
510(k) number
K151976
Product code
FAS  
Decision
Substantially Equivalent (SESE)
Decision date
2016-06-27
Date received
2015-07-16
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
JON D. BARRETT
Address
450 S. Campbell St. Suite #2 Valparaiso IN US 46385 46385

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
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#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases