FDA.report

Electrosurgical system generator

Definition
A mains electricity-powered (AC-powered) component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
GUDID devices
595
Last updated
2023-03-02 07:31:50

Related Product Codes

CodeDeviceSpecialtyClassDevices
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2500
FYDApparatus, Exhaust, SurgicalGeneral, Plastic Surgery240
BWAUnit, Electrosurgical And Coagulation, With AccessoriesGeneral, Plastic Surgery223
HGIElectrocautery, Gynecologic (And Accessories)Obstetrics/Gynecology218
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology29
KNWInstrument, BiopsyGastroenterology, Urology29
MWYSystem, Microwave, Hair RemovalGeneral, Plastic Surgery24
FDISnare, FlexibleGastroenterology, Urology22
EKZUnit, Electrosurgical, And Accessories, DentalDental21
GAZTubing, NoninvasiveGeneral Hospital21
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital21
HIHHysteroscope (And Accessories)Obstetrics/Gynecology21
HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)Obstetrics/Gynecology21
HRXArthroscopeOrthopedic21
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery11
NAYSystem, Surgical, Computer Controlled InstrumentGastroenterology, Urology21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
20193489085355MedlineMEDLINE INDUSTRIES, INC.ESSHROUD102023-02-22
30193489085345MedlineMEDLINE INDUSTRIES, INC.ESSHROUD12023-02-22
00817470001594QUANTUM 2Smith & Nephew, Inc.28168-592023-02-15
00817470001792COBLATOR II Controller 120V (SRVC controller-only)Smith & Nephew, Inc.13546-592023-02-15
00817470001938COBLATOR II Controller 240V (SRVC controller-only)Smith & Nephew, Inc.13546-582023-02-15
00817470002072Foot ControlSmith & Nephew, Inc.H3000-012023-02-14
00817470002157COBLATOR II Flow ValveSmith & Nephew, Inc.EA8002-002023-02-14
00817470002171Foot Control, ShieldedSmith & Nephew, Inc.H3000-032023-02-14
00888937025101LEEP PRECISION™ Integrated SystemCoopersurgical, Inc.LP-10-2202023-01-04
00801741218033WavelinQCLEARSTREAM TECHNOLOGIES LIMITEDESU22022-11-17
00841019121238KirwanKIRWAN SURGICAL PRODUCTS LLC26-2520S2022-11-02
00190776214012MillenniumAVALIGN TECHNOLOGIES, INC.72-59912022-10-26
08800017100883VYBE RFshenb Co., Ltd.VYBE RF2022-09-19
10884521783843SurgiStatCovidien LPVLSURGGENZE2022-08-15
10884521512085Force EZCovidien LPForceEZ8C2016-09-24
04042768910012OlympusOLYMPUS Winter & Ibe GmbHWB9910012016-09-21
04042768910074OlympusOLYMPUS Winter & Ibe GmbHWB9910072016-09-21
10884524002613Force FXCovidien LPFORCEFXC2016-09-25
10884521546219LigaSureCovidien LPLIGASUREZD2018-09-08
10884524002767LigaSureCovidien LPLigaSure 82016-09-24
10884521707306Valleylab FX8Covidien LPVLFX8GEN2018-01-05
10884521512801Valleylab LS10Covidien LPVLLS10GEN2018-03-18
10884521516328Valleylab FT10Covidien LPVLFT10GEN2017-09-29
10884521548350Valleylab FT10Covidien LPVLFT10GEN2016-09-24
10884521640474Valleylab FT10Covidien LPVLFT10GENZD2017-06-28
10884521780583Valleylab LS10Covidien LPVLLS10GEN2018-12-02
04038653078035AESCULAPAesculap AGGN0602016-09-23
10705031200517GYNECARE VERSAPOINTETHICON INC.004652016-09-16
00190776162474MillenniumAVALIGN TECHNOLOGIES, INC.72-52005912021-11-30
10884524002651Force EZCovidien LPForce EZ-C2021-11-11
00885556804513WEREWOLF+Smith & Nephew, Inc.722901712021-11-01
00885556804520WEREWOLF+Smith & Nephew, Inc.722901722021-11-01
00885556804537WEREWOLF+Smith & Nephew, Inc.722901732021-11-01
00885556804575WEREWOLF+Smith & Nephew, Inc.722901772021-11-01
00885556804612WEREWOLF+Smith & Nephew, Inc.722901822021-11-01
04046964013638AESCULAPAesculap AGGN2002016-09-23
00841019120422KirwanKIRWAN SURGICAL PRODUCTS LLC26-2520S2021-09-28
04042761085977OlympusOLYMPUS Winter & Ibe GmbHWA90300W2018-10-30
10884521780415Valleylab FX8Covidien LPVLFX8GENZE2021-09-09
04042761086332OlympusOLYMPUS Winter & Ibe GmbHWA91307W2021-08-18
04042761086349OlympusOLYMPUS Winter & Ibe GmbHWA91307C2021-08-18
0084149410510560MM HANDPIECE W/ACC, TEMPSURECynosure, Inc.100-7027-1652021-07-16
00885556787236WEREWOLF+Smith & Nephew, Inc.722901462021-07-01
00885556793725WEREWOLF+Smith & Nephew, Inc.72290146S2021-07-01
00885556793732WEREWOLF+Smith & Nephew, Inc.72290146F2021-07-01
00885556804490WEREWOLF+Smith & Nephew, Inc.722901782021-07-01
00885556804544WEREWOLF+Smith & Nephew, Inc.722901742021-07-01
00885556804568WEREWOLF+Smith & Nephew, Inc.722901762021-07-01
30614559104051MegadyneMEGADYNE MEDICAL PRODUCTS, INC.0019BN2016-12-07
30614559104167MegadyneMEGADYNE MEDICAL PRODUCTS, INC.0014MP2018-09-04
30614559104181ZIP PenMEGADYNE MEDICAL PRODUCTS, INC.25402016-12-14
30614559104198ZIP PenMEGADYNE MEDICAL PRODUCTS, INC.25602016-12-14
30614559104990MEGADYNEMEGADYNE MEDICAL PRODUCTS, INC.2525-10BN2019-02-01
00190776159450millenniumAVALIGN TECHNOLOGIES, INC.72-50142021-05-27
00190776159443MillenniumAVALIGN TECHNOLOGIES, INC.72-5903012021-05-25
10614559100943Mega 2000MEGADYNE MEDICAL PRODUCTS, INC.08252018-09-05
10614559105337ZIP PenMEGADYNE MEDICAL PRODUCTS, INC.2525102018-09-04
10653405031598HYFRECATOR 2000Conmed Corporation7-900-1152016-09-24
10884521031913ForceTriadCovidien LPFTRCKIT2016-09-24
10884521035379ForceTriadCovidien LPFTBRKIT2017-03-22
30614559100947Mega 2000MEGADYNE MEDICAL PRODUCTS, INC.08252018-09-05
10653405061410ALTRUSConmed Corporation60-9500-1202020-12-13
00850346007023CoolSeal™ GeneratorJUSTRIGHT SURGICAL, LLCCSL-200-502020-10-13
00190776155315MillenniumAVALIGN TECHNOLOGIES, INC.72-31573302020-09-29
00190776155292MillenniumAVALIGN TECHNOLOGIES, INC.72-315712062020-09-25
00190776155308MillenniumAVALIGN TECHNOLOGIES, INC.72-315712082020-09-25
10614559105634MEGADYNEMEGADYNE MEDICAL PRODUCTS, INC.1459J2020-09-24
10614559100639MegadyneMEGADYNE MEDICAL PRODUCTS, INC.00752016-12-08
10614559100936Mega 2000MEGADYNE MEDICAL PRODUCTS, INC.08002016-12-11
30614559100435MegadyneMEGADYNE MEDICAL PRODUCTS, INC.00242016-12-06
30614559100527MegadyneMEGADYNE MEDICAL PRODUCTS, INC.00552016-12-08
30614559100534MegadyneMEGADYNE MEDICAL PRODUCTS, INC.00602016-12-08
30614559100558MegadyneMEGADYNE MEDICAL PRODUCTS, INC.00622016-12-08
30614559100565MegadyneMEGADYNE MEDICAL PRODUCTS, INC.00632016-12-08
30614559100572MegadyneMEGADYNE MEDICAL PRODUCTS, INC.00642016-12-08
30614559100589MegadyneMEGADYNE MEDICAL PRODUCTS, INC.00662016-12-08
30614559100640MegadyneMEGADYNE MEDICAL PRODUCTS, INC.00802016-12-08
30614559100657MegadyneMEGADYNE MEDICAL PRODUCTS, INC.00852016-12-08
30614559100664MegadyneMEGADYNE MEDICAL PRODUCTS, INC.01002016-12-08
30614559100671MegadyneMEGADYNE MEDICAL PRODUCTS, INC.0100S2016-12-08