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
619
Last updated
2026-08-28 10:20:26

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00607151011161BANTAM / PROASPEN SURGICAL PRODUCTS, INC.A9522016-11-21
00607151011178BANTAM / PROASPEN SURGICAL PRODUCTS, INC.A9422016-12-16
10607151002074BovieASPEN SURGICAL PRODUCTS, INC.GP3002016-10-13
10607151002319BovieASPEN SURGICAL PRODUCTS, INC.A9502016-10-13
10607151002562BovieASPEN SURGICAL PRODUCTS, INC.A1250U2016-10-13
10607151002784BovieASPEN SURGICAL PRODUCTS, INC.A2250-LOANER2016-10-13
10607151002791BovieASPEN SURGICAL PRODUCTS, INC.IDS-300-LOANER2016-10-13
10607151002807BovieASPEN SURGICAL PRODUCTS, INC.IDS-200-LOANER2016-10-13
10607151003101BovieASPEN SURGICAL PRODUCTS, INC.A3250-LOANER2016-10-13
10607151005334BovieASPEN SURGICAL PRODUCTS, INC.A9402016-10-13
10607151005358BovieASPEN SURGICAL PRODUCTS, INC.GP300-LOANER2016-10-13
10607151005365BovieASPEN SURGICAL PRODUCTS, INC.A940-LOANER2016-10-13
10607151005976BovieASPEN SURGICAL PRODUCTS, INC.A940-P2016-10-13
10607151006744BovieASPEN SURGICAL PRODUCTS, INC.A827F2019-06-17
10607151006805BovieASPEN SURGICAL PRODUCTS, INC.A1250U-V2016-10-13
10607151006812BovieASPEN SURGICAL PRODUCTS, INC.A940-V2016-10-13
10607151008014BovieASPEN SURGICAL PRODUCTS, INC.A1250U-V-DEMO2016-10-13
10607151008021BovieASPEN SURGICAL PRODUCTS, INC.A1250U-V-LOANER2016-10-13
10607151008052BovieASPEN SURGICAL PRODUCTS, INC.A940-TRAB2016-10-13
10607151008182BovieASPEN SURGICAL PRODUCTS, INC.A2250-REFURBISHED2016-10-13
10607151008199BovieASPEN SURGICAL PRODUCTS, INC.A3250-REFURBISHED2016-10-13
10607151008205BovieASPEN SURGICAL PRODUCTS, INC.IDS-200-REFURBISHED2016-10-13
10607151008212BovieASPEN SURGICAL PRODUCTS, INC.IDS-400-REFURBISHED2016-10-13
10607151008250BovieASPEN SURGICAL PRODUCTS, INC.GS100-DEMO2016-10-13
10607151008267BovieASPEN SURGICAL PRODUCTS, INC.GS100-LOANER2016-10-13
10607151008281BovieASPEN SURGICAL PRODUCTS, INC.IDS-400-DEMO2016-10-13
10607151008519BovieASPEN SURGICAL PRODUCTS, INC.GP300-DEMO2016-10-13
10607151008533BovieASPEN SURGICAL PRODUCTS, INC.A1250U-VP2016-10-13
10607151008540BovieASPEN SURGICAL PRODUCTS, INC.A940-VP2016-10-13
10607151008946BovieASPEN SURGICAL PRODUCTS, INC.IDS-3102016-10-13
10607151009028BovieASPEN SURGICAL PRODUCTS, INC.GP300-REFURBISHED2016-10-13
10607151009769BOVIE ULTIMATEASPEN SURGICAL PRODUCTS, INC.BVX-100H2016-10-13
10607151010024BovieASPEN SURGICAL PRODUCTS, INC.IDS-2102016-10-13
10607151010031BovieASPEN SURGICAL PRODUCTS, INC.A32502016-10-13
10607151010109BovieASPEN SURGICAL PRODUCTS, INC.IDS-310-DEMO2016-10-13
10607151010123BOVIE ULTIMATEASPEN SURGICAL PRODUCTS, INC.BVX-100H-DEMO2016-10-13
10607151010130BovieASPEN SURGICAL PRODUCTS, INC.IDS-210-DEMO2016-10-13
10607151010765BovieASPEN SURGICAL PRODUCTS, INC.IDS-310T2016-10-13
10607151010789BovieASPEN SURGICAL PRODUCTS, INC.IDS-310-LOANER2016-10-13
00821925008304Gyrus ACMIGyrus ACMI, LLC5686182016-10-03
00821925034433Gyrus ACMIGyrus ACMI, LLC1315002016-10-07
08800020110688INTRAGen HandpieceJeisys Medical Inc.INTRAGen Handpiece2026-07-29
08800020100481POTENZA TipJeisys Medical Inc.CP-21 TIP2026-07-21
08800020101754POTENZA HandpieceJeisys Medical Inc.AC Handpiece2026-07-21
08800020101761POTENZA HandpieceJeisys Medical Inc.S Handpiece2026-07-21
08800020101778POTENZA HandpieceJeisys Medical Inc.Motor Handpiece2026-07-21
08800020110541INTRAcel PremiumJeisys Medical Inc.INTRAcel Premium Fractional RF Micro Needle (FRM) 2026-07-21
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