FDA.reportPublic FDA data

Electrosurgical handpiece, single-use

Definition
A sterile hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during argon-enhanced electrosurgery. This is a single-use device.
GUDID devices
222
Last updated
2022-11-11 10:47:02

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
G3731420010Zinnanti SurgicalZinnanti Surgical Design Group Inc14-20012022-11-03
G373SEP2A0Arms MedicalZinnanti Surgical Design Group IncSEP2A2022-10-31
00607151050184Renuvion®APYX MEDICAL CORPORATIONAPYX-044-DERM2022-07-01
00607151050214Renuvion®APYX MEDICAL CORPORATIONAPYX-DERM-SP2022-07-01
B560Z20200ZEPTO Precision Capsulotomy SystemMYNOSYS CELLULAR DEVICES, INC.Z20202021-11-23
10612479209104McKessonMCKESSON MEDICAL-SURGICAL INC.22-ESP12016-12-09
10612479209128McKessonMCKESSON MEDICAL-SURGICAL INC.22-ESP1H2016-12-09
10612479209142McKessonMCKESSON MEDICAL-SURGICAL INC.22-ESP1TNH2016-12-09
10612479209166McKessonMCKESSON MEDICAL-SURGICAL INC.22-ESP62016-12-09
10612479209180McKessonMCKESSON MEDICAL-SURGICAL INC.22-ESP6H2016-12-09
08964000207000TecnoTECNO INSTRUMENTS (PVT) LTD150-1002021-06-30
30884389161115MedlineMEDLINE INDUSTRIES, INC.ESRK3002V2021-06-09
30884389161122MedlineMEDLINE INDUSTRIES, INC.ESPB3002V2021-06-09
40884389161136MedlineMEDLINE INDUSTRIES, INC.ESRK3000V2021-06-09
10614559102565MegadyneMEGADYNE MEDICAL PRODUCTS, INC.3030HT2016-12-14
10614559102572MegadyneMEGADYNE MEDICAL PRODUCTS, INC.3035HT2016-12-14
20815288010719AEM® Disposable Handswitching Handpiece with Rocker SwitchENCISION, INC.ES13002016-08-31
00810026181023Sp-TipSONIQUENCE, LLCSST-W2021-01-18
00810026181030SP-TipSONIQUENCE, LLCSST-L32021-01-18
00810026181047Sp-TipSONIQUENCE, LLCSST-B22021-01-18
00810026181054Sp-TipSONIQUENCE, LLCSST-B32021-01-18
00810026181061Sp-TipSONIQUENCE, LLCSST-N2021-01-18
00810026181078Sp-TipSONIQUENCE, LLCSST-S2021-01-18
00810026181085Sp-TipSONIQUENCE, LLCSST-L52021-01-18
00810026181092Sp-TipSONIQUENCE, LLCSST-L102021-01-18
00810026181016SP-KitSONIQUENCE, LLCSSP-012021-01-14
10193489017724MedlineMEDLINE INDUSTRIES, INC.ESPB3002P2020-12-10
10193489017731MedlineMEDLINE INDUSTRIES, INC.ESRK3002P2020-12-10
00850017374003Plasma IQ SystemNEAUVIA NORTH AMERICA, INC.PLK-7552020-09-14
00850017374010Plasma IQ Electrode Straight (1 piece)NEAUVIA NORTH AMERICA, INC.AEP-1012020-09-14
00850017374027Plasma IQ Electrode Straight (10 piece)NEAUVIA NORTH AMERICA, INC.AES-1012020-09-14
00850017374034Plasma IQ Docking StationNEAUVIA NORTH AMERICA, INC.PCG-7242020-09-14
00850017374041Plasma IQ HandpieceNEAUVIA NORTH AMERICA, INC.PLA-7522020-09-14
00850017374102Plasma IQ Electrode Curved (1 piece)NEAUVIA NORTH AMERICA, INC.AEP-1022020-09-14
00850017374119Plasma IQ Electrode Curved (10 piece)NEAUVIA NORTH AMERICA, INC.AES-1022020-09-14
16924274957161Peng’s Multifunctional Operative Dissector(PMOD)Zhejiang Shuyou Surgical Instrument Co.,Ltd.ISEP10002020-07-17
08800023201376Secret RF SmartcureILOODA.CO.,LTDMTR 2.0 Smartcure2020-07-01
00810026180613Fingerswitch Wand SONIQUENCE, LLCSIEC-3FHPB/D12020-04-30
008414941054333-BUTTON FINGERSWITCH HPCynosure, LLCIEC-3FHPB/D2016-09-21
008414941071093 Button FSHPCynosure, LLCIEC-3FHPB/D12017-01-27
23596010252191NASmith & Nephew, Inc.72054402015-10-05
H671ESU3052N/AUTAH MEDICAL PRODUCTS, INC.N/A2016-09-23
H671ESU3062N/AUTAH MEDICAL PRODUCTS, INC.N/A2016-09-23
00852306007708TRIO HandpieceOMNIGUIDE, INC.12019-06-06
20612479227402McKessonMCKESSON MEDICAL-SURGICAL INC.22-H101122018-02-05
20612479227419McKessonMCKESSON MEDICAL-SURGICAL INC.22-H100122018-02-05
20612479227426McKessonMCKESSON MEDICAL-SURGICAL INC.22-H101082018-02-05
20612479227433McKessonMCKESSON MEDICAL-SURGICAL INC.22-H100082018-02-05
20787551000065"ES Pencil Button Switch 2.75"" Needle Electrode Stainless Steel"XODUS MEDICAL, INC.214002017-04-21
20787551000072"ES Pencil Rocker Switch 2.75"" Needle Electrode Stainless Steel"XODUS MEDICAL, INC.214102017-04-21
20787551000089"ES Pencil Button 2.75"" Needle Electrode Ext Insulation Stainless Steel"XODUS MEDICAL, INC.214202017-04-21
20787551000126"ES Pencil Rocker 2.75"" Needle Electrode Ext Insulation Stainless Steel"XODUS MEDICAL, INC.214302017-04-21
20787551000133ES Pencil Button 2.75" Blade Electrode Stainless SXODUS MEDICAL, INC.214402017-04-21
20787551000140ES Pencil Rocker 2.75" Blade Electrode Stainless SXODUS MEDICAL, INC.214502017-04-21
20787551000157ES Pencil Button with Holster 2.5" Blade ElectrodeXODUS MEDICAL, INC.215002017-04-21
20787551000164"ES Pencil Button 2.5"" Blade Electrode Ext Insulation Stainless Steel"XODUS MEDICAL, INC.215202017-04-21
20787551000171ES Pencil Button 2.75" Blade Electrode Ext InsulatXODUS MEDICAL, INC.215302017-04-21
20787551000188ES Pencil Rocker 2.75" Blade Electrode Ext InsulatXODUS MEDICAL, INC.215402017-04-21
20787551000195ES Pencil Rocker with Holster 2.5" Blade ElectrodeXODUS MEDICAL, INC.215502017-04-21
20787551000201"ES Pencil Rocker 2.5"" Blade Electrode Ext Insulation Stainless Steel"XODUS MEDICAL, INC.215702017-04-21
20787551000218"ES Pencil Button with Holster 4"" Blade Electrode Stainless Steel"XODUS MEDICAL, INC.216102017-04-21
20787551000225"ES Pencil Button with Holster 6.5"" Blade Electrode Stainless Steel"XODUS MEDICAL, INC.216202017-04-21
20787551000232"ES Pencil Rocker with Holster 4"" Blade Electrode Stainless Steel"XODUS MEDICAL, INC.216302017-04-21
20787551000249"ES Pencil Rocker with Holster 6.5"" Blade Electrode Stainless Steel"XODUS MEDICAL, INC.216402017-04-21
20787551000256"ES Pencil Button Switch with Holster 4"" Blade Electrode PTFE Coated"XODUS MEDICAL, INC.216602017-04-21
20787551000263"ES Pencil Button Switch with Holster 6.5"" Blade Electrode PTFE Coated"XODUS MEDICAL, INC.216702017-04-21
20787551000270"ES Pencil Rocker Switch with Holster 4"" Blade Electrode PTFE Coated"XODUS MEDICAL, INC.216802017-04-21
20787551000287"ES Pencil Rocker Switch with Holster 6.5"" Blade Electrode PTFE Coated"XODUS MEDICAL, INC.216902017-04-21
20787551000294ES Pencil Button Switch with Holster 2.5" Blade ElXODUS MEDICAL, INC.218002017-04-21
20787551000300"ES Pencil Button 4"" Blade Electrode Ext Insulation PTFE Coated"XODUS MEDICAL, INC.218102017-04-21
20787551000317ES Pencil Button 2.5" Blade Electrode Ext InsulatiXODUS MEDICAL, INC.218202017-04-21
20787551000324"ES Pencil Button Switch with Holster 5"" Ball Electrode PTFE Coated"XODUS MEDICAL, INC.218302017-04-21
20787551000331"ES Pencil Button 6.5"" Blade Electrode Ext Insulation PTFE Coated"XODUS MEDICAL, INC.218402017-04-21
20787551000348ES Pencil Rocker Switch with Holster 2.5" Blade ElXODUS MEDICAL, INC.218502017-04-21
20787551000355"ES Pencil Rocker 4"" Blade Electrode Ext Insulation PTFE Coated"XODUS MEDICAL, INC.218602017-04-21
20787551000362ES Pencil Rocker 2.5" Blade Electrode Ext InsulatiXODUS MEDICAL, INC.218702017-04-21
20787551000379"ES Pencil Rocker 6.5"" Blade Electrode Ext Insulation PTFE Coated"XODUS MEDICAL, INC.218802017-04-21
20787551000386"ES Pencil Rocker Switch with Holster 5"" Ball Electrode PTFE Coated"XODUS MEDICAL, INC.218902017-04-21
20787551000393ES Pencil Button with Holster 2.75" Needle ElectroXODUS MEDICAL, INC.219102017-04-21
20787551000409ES Pencil Rocker with Holster 2.75" Needle ElectroXODUS MEDICAL, INC.219202017-04-21