FDA.reportPublic FDA data

Electrosurgical system

Definition
An assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation 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). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery.
GUDID devices
600
Last updated
2026-07-25 06:05:11

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08800020100276INTRAcel TipJeisys Medical Inc.INTRAcel Tip 10102026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.INTRAcel Tip 32026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.INTRAcel Tip 10122026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.INTRAcel Tip 10132026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.INTRAcel Tip 20112026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.N16 Tip2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.INTRAcel Handpiece2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.INTRAcel PRO Handpiece2026-07-16
08800020110640FootswitchJeisys Medical Inc.INTRAcel Foot Switch2026-07-16
08800020101013INTRAcelJeisys Medical Inc.INTRAcel2016-10-03
08800020101020INTRAcel TipJeisys Medical Inc.10112016-10-03
08800020100238POTENZA TipJeisys Medical Inc.I-49 Tip2021-04-02
08800020100245POTENZA TipJeisys Medical Inc.S-49 Tip2021-04-02
08800020100252POTENZA TipJeisys Medical Inc.I-25 Tip2021-04-02
08800020100269POTENZA TipJeisys Medical Inc.S-25 Tip2021-04-02
08800020101136POTENZA TipJeisys Medical Inc.A1-122022-03-29
08800020101143POTENZA TipJeisys Medical Inc.A1-152022-03-29
08800020101150POTENZA TipJeisys Medical Inc.C21-1 Tip2022-03-29
08800020101167POTENZA TipJeisys Medical Inc.C21-2 Tip2022-03-29
08800020101174POTENZA TipJeisys Medical Inc.C9 Tip2022-03-29
08800020101181POTENZA TipJeisys Medical Inc.I-16 Tip2022-03-29
08800020101198POTENZA TipJeisys Medical Inc.S-16 Tip2022-03-29
08800020101204POTENZA TipJeisys Medical Inc.P1-082022-03-29
08800020105509POTENZA TipJeisys Medical Inc.CP-252025-05-19
08800020105615POTENZA TipJeisys Medical Inc.CP-162025-05-19
08800020105622POTENZA TipJeisys Medical Inc.CP-492025-05-19
08800020106292POTENZA TipJeisys Medical Inc.DDR Tip2025-05-19
08800020106308POTENZA TipJeisys Medical Inc.SFA Tip2025-05-19
08800020107282POTENZA TipJeisys Medical Inc.Diamond Tip2026-03-10
08800020108395POTENZAJeisys Medical Inc.Foot Switch2026-03-16
08800020111012POTENZAJeisys Medical Inc.POTENZA2020-02-27
00821925034730Gyrus ACMIGyrus ACMI, LLC703531002017-05-11
00821925034754Gyrus ACMIGyrus ACMI, LLC703531122017-05-11
00821925010567Gyrus ACMIGyrus ACMI, LLC39992024-07-24
00860015792006NOVOCLEAR™ DeviceAventix Medical Inc.CLR0012026-06-09
00860015792013AVENTIX® PFX SystemAventix Medical Inc.PFX012026-06-09
04548213056545Root ZX3J.MORITA MFG.CORP.RZX3 Type: HF2023-06-27
08886479300306RhinAer+ StylusAerin Medical Inc.FG22582025-09-19
00607151010263BovieASPEN SURGICAL PRODUCTS, INC.A1250S2018-02-23
00607915117856VOYANT® 5mm Fusion Device APPLIED MEDICAL RESOURCES CORPORATIONEB0102016-09-24
00607915127428Voyant® Fine Fusion DeviceAPPLIED MEDICAL RESOURCES CORPORATIONEB0302016-09-23
00607915134754VOYANT® 5mm Fusion Device APPLIED MEDICAL RESOURCES CORPORATIONEB0112016-09-24
00607915136956VOYANT® Maryland Fusion DeviceAPPLIED MEDICAL RESOURCES CORPORATIONEB0152019-01-21
00607915136963VOYANT® Maryland Fusion DeviceAPPLIED MEDICAL RESOURCES CORPORATIONEB0162019-01-21
00607915137953Voyant Open Fusion DeviceAPPLIED MEDICAL RESOURCES CORPORATIONEB0402017-02-07
00607915138240VOYANT® Fine Fusion DeviceAPPLIED MEDICAL RESOURCES CORPORATIONEB2302019-01-28
00607915138424VOYANT® 5mm Fusion Device APPLIED MEDICAL RESOURCES CORPORATIONEB2102019-01-28
00607915138431VOYANT® 5mm Fusion Device APPLIED MEDICAL RESOURCES CORPORATIONEB2112019-01-28
00607915138455Voyant Open Fusion DeviceAPPLIED MEDICAL RESOURCES CORPORATIONEB2402019-01-28
00607915138547VOYANT® Maryland Fusion DeviceAPPLIED MEDICAL RESOURCES CORPORATIONEB0172019-01-21
00607915139353VOYANT® Maryland Fusion DeviceAPPLIED MEDICAL RESOURCES CORPORATIONEB2152019-01-28
00607915139360VOYANT® Maryland Fusion DeviceAPPLIED MEDICAL RESOURCES CORPORATIONEB2162019-01-28
00607915139377VOYANT® Maryland Fusion DeviceAPPLIED MEDICAL RESOURCES CORPORATIONEB2172019-01-28
00607915140793Voyant Maryland Fusion Device with Single-Step ActivationAPPLIED MEDICAL RESOURCES CORPORATIONEB2122022-12-13
00607915140816Voyant Maryland Fusion Device with Single-Step ActivationAPPLIED MEDICAL RESOURCES CORPORATIONEB2142022-12-13
00749756053297DeRoyalDEROYAL INDUSTRIES, INC.88-0001022016-09-12
00749756137584DeRoyalDEROYAL INDUSTRIES, INC.BB-12016-09-12
00749756138147DeRoyalDEROYAL INDUSTRIES, INC.RB-12016-09-12
00749756142007DeRoyalDEROYAL INDUSTRIES, INC.88-0002012016-09-12
00749756142014DeRoyalDEROYAL INDUSTRIES, INC.88-0002022016-09-12
00749756157742DeRoyalDEROYAL INDUSTRIES, INC.88-0015012016-09-12
00749756157759DeRoyalDEROYAL INDUSTRIES, INC.88-0015022016-09-12
00749756157766DeRoyalDEROYAL INDUSTRIES, INC.88-0015212016-09-12
00749756157773DeRoyalDEROYAL INDUSTRIES, INC.88-0015222016-09-12
00749756157896DeRoyalDEROYAL INDUSTRIES, INC.88-0025162016-09-12
00749756157902DeRoyalDEROYAL INDUSTRIES, INC.88-0025152016-09-12
00749756157940DeRoyalDEROYAL INDUSTRIES, INC.88-0024502016-09-12
00749756158039DeRoyalDEROYAL INDUSTRIES, INC.88-1015022016-09-12
00749756158046DeRoyalDEROYAL INDUSTRIES, INC.88-1015222016-09-12
00749756162760DeRoyalDEROYAL INDUSTRIES, INC.88-1032016-09-12
00749756165280DeRoyalDEROYAL INDUSTRIES, INC.88-0023502016-09-12
00749756248136DeRoyalDEROYAL INDUSTRIES, INC.KW-30-52002016-09-12
00749756267397DeRoyalDEROYAL INDUSTRIES, INC.88-15102016-09-12
00749756277273DeRoyalDEROYAL INDUSTRIES, INC.88-15112016-09-12
00749756277280DeRoyalDEROYAL INDUSTRIES, INC.88-1511NS2016-09-12
00749756277327DeRoyalDEROYAL INDUSTRIES, INC.88-15132016-09-12
00749756277334DeRoyalDEROYAL INDUSTRIES, INC.88-15122016-09-12
00749756279994DeRoyalDEROYAL INDUSTRIES, INC.88-1042016-09-12
00749756283489DeRoyalDEROYAL INDUSTRIES, INC.88-25102016-09-12
00749756301954DeRoyalDEROYAL INDUSTRIES, INC.88-0002222016-09-12