FDA.reportPublic FDA data

Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

Definition
A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use device.
GUDID devices
820
Last updated
2026-07-21 06:05:24

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00821925033900DIEGOGyrus ACMI, LLC701390022024-07-25
00821925033917DIEGOGyrus ACMI, LLC701390062024-07-24
00821925034419DIEGOGyrus ACMI, LLC701390332024-07-23
00821925035935OLYMPUSGyrus ACMI, LLC37402016-10-03
10884521039100ValleylabCovidien LPE3310NSB2016-09-24
00821925035874OLYMPUSGyrus ACMI, LLC30002016-09-30
00821925035911Gyrus ACMIGyrus ACMI, LLC34002016-10-12
00821925041547Gyrus ACMIGyrus ACMI, LLC30252016-09-30
00813527028590E SurgicalNEW DEANTRONICS TAIWAN LTD.RB3490-012026-06-23
00813527028613E SurgicalNEW DEANTRONICS TAIWAN LTD.RB3455-012026-06-23
00813527028637E SurgicalNEW DEANTRONICS TAIWAN LTD.RB0700-212026-06-23
00813527028651E SurgicalNEW DEANTRONICS TAIWAN LTD.RB2000-112026-06-23
00813527028675E SurgicalNEW DEANTRONICS TAIWAN LTD.RB2040-112026-06-23
00813527028699E SurgicalNEW DEANTRONICS TAIWAN LTD.RB4090A-022026-06-23
00813527028712E SurgicalNEW DEANTRONICS TAIWAN LTD.RB4090-022026-06-23
00813527028736E SurgicalNEW DEANTRONICS TAIWAN LTD.RB4050A-022026-06-23
00813527028750E SurgicalNEW DEANTRONICS TAIWAN LTD.RB4050-022026-06-23
00813527028774E SurgicalNEW DEANTRONICS TAIWAN LTD.RB2790-012026-06-23
00813527028798E SurgicalNEW DEANTRONICS TAIWAN LTD.RB2760-012026-06-23
00813527028811E SurgicalNEW DEANTRONICS TAIWAN LTD.RB2790-002026-06-23
00813527028835E SurgicalNEW DEANTRONICS TAIWAN LTD.RB2760-002026-06-23
00813527028859E SurgicalNEW DEANTRONICS TAIWAN LTD.RB4050-012026-06-23
00813527028873E SurgicalNEW DEANTRONICS TAIWAN LTD.RB4050A-012026-06-23
00813527028897E SurgicalNEW DEANTRONICS TAIWAN LTD.RB4090-012026-06-23
00813527028910E SurgicalNEW DEANTRONICS TAIWAN LTD.RB4090A-012026-06-23
00821925035898OLYMPUSGyrus ACMI, LLC30062016-09-30
00821925041554OLYMPUSGyrus ACMI, LLC30452016-09-30
10884524001500ValleylabCovidien LPE2516HS2016-09-24
00846338007133Trigger-Flex Quad Pro Bipolar SystemELLIQUENCE, LLCDTFQM-242026-06-02
07290119640072ENTire IRE SystemENTIRE MEDICAL LTDNasal Handpiece2026-02-24
07290119640089ENTire IRE SystemENTIRE MEDICAL LTDNasal Handpiece2026-02-24
07290119640096ENTire IRE SystemENTIRE MEDICAL LTDTonsil Handpiece2026-02-24
07290119640102ENTire IRE SystemENTIRE MEDICAL LTDTonsil Handpiece2026-02-24
07290119640119ENTire IRE SystemENTIRE MEDICAL LTDTonsil Handpiece2026-02-24
00607151010799BOVIEASPEN SURGICAL PRODUCTS, INC.BA3350A2016-10-07
00607151010812BOVIEASPEN SURGICAL PRODUCTS, INC.BA3390A2016-10-07
00607151010829BOVIEASPEN SURGICAL PRODUCTS, INC.BA3390NA2016-10-07
00607151010836BOVIEASPEN SURGICAL PRODUCTS, INC.BA3350NA2016-10-07
00607151010843BOVIEASPEN SURGICAL PRODUCTS, INC.BA2455NA2016-10-07
00607151010850BOVIEASPEN SURGICAL PRODUCTS, INC.BA1860NA2016-10-07
00803622132360VascuClear EVHLIVANOVA USA, INC.VascuClear EVH2016-06-15
00803622132377VascuClear EVHLIVANOVA USA, INC.VascuClear EVH2016-06-15
00803622132384VascuClear EVHLIVANOVA USA, INC.VascuClear EVH2016-06-15
00803622132391VascuClear EVHLIVANOVA USA, INC.VascuClear EVH2016-06-15
00803622132407VascuClear EVHLIVANOVA USA, INC.VascuClear EVH2016-06-15
00803622132414VascuClear EVHLIVANOVA USA, INC.VascuClear EVH2016-06-15
00803622132421VascuClear EVHLIVANOVA USA, INC.VascuClear EVH2016-06-15
00803622132438VascuClear EVHLIVANOVA USA, INC.VascuClear EVH2016-06-15
00803622132445VascuClear EVHLIVANOVA USA, INC.VascuClear EVH2016-06-15
00803622132452Precision BipolarLIVANOVA USA, INC.PBD022016-06-15
00817984010907Bipolar ForcepsMECTRA LABS, INC.0600-BC3310-0002019-01-24
00817984010914Bipolar ForcepsMECTRA LABS, INC.0600-BC3320-0002019-01-25
00821925034044Gyrus ACMIGyrus ACMI, LLC2220-2210-052016-10-11
00821925034723DIEGOGyrus ACMI, LLC701390082024-07-25
00821925034778PK TECHNOLOGYGyrus ACMI, LLC910000PK2016-10-04
00821925035881OLYMPUSGyrus ACMI, LLC30052016-10-11
00821925035904OLYMPUSGyrus ACMI, LLC33002016-10-03
00821925035928OLYMPUSGyrus ACMI, LLC37002016-10-03
00821925035959PlasmaKineticGyrus ACMI, LLC7145002016-10-06
00821925035966PlasmaKineticGyrus ACMI, LLC7145102018-09-13
00821925035997PK TECHNOLOGYGyrus ACMI, LLC3000PK2016-09-30
00821925036000PK TECHNOLOGYGyrus ACMI, LLC3005PK2016-10-11
00821925036017PK TECHNOLOGYGyrus ACMI, LLC3015PK2016-09-30
00821925036024PK TECHNOLOGYGyrus ACMI, LLC3025PK2016-09-30
00821925036031PK TECHNOLOGYGyrus ACMI, LLC3045PK2016-10-03
00821925036048PK TECHNOLOGYGyrus ACMI, LLC3103PK2016-10-11
00821925036055PK TECHNOLOGYGyrus ACMI, LLC3200PK2016-10-11
00821925036062PK TECHNOLOGYGyrus ACMI, LLC3300PK2016-10-11
00821925036079PK TECHNOLOGYGyrus ACMI, LLC3330PK2016-10-11
00821925036086PK TECHNOLOGYGyrus ACMI, LLC3400PK2016-10-12
00821925036093PK TECHNOLOGYGyrus ACMI, LLC3600PK2016-10-03
00821925036109PK TECHNOLOGYGyrus ACMI, LLC3700PK2016-10-12
00821925036116PK TECHNOLOGYGyrus ACMI, LLC3720PK2016-10-03
00821925036123PK TECHNOLOGYGyrus ACMI, LLC3740PK2016-10-03
00821925036178PK TECHNOLOGYGyrus ACMI, LLC920005PK2016-10-12
00821925036185PK TECHNOLOGYGyrus ACMI, LLC920010PK2016-10-04
00821925036192PK TECHNOLOGYGyrus ACMI, LLC921015PK2016-10-12
00821925036208PK TECHNOLOGYGyrus ACMI, LLC921020PK2016-10-12
00821925036215PK TECHNOLOGYGyrus ACMI, LLC942000PK2016-10-04
00821925036222PK TECHNOLOGYGyrus ACMI, LLC942005PK2016-10-12