GEI

Electrosurgical, Cutting & Coagulation & Accessories

Product code
GEI
Device name
Electrosurgical, Cutting & Coagulation & Accessories
Device class
Class 2
21 CFR
21 CFR 878.4400
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
2314

FDA classification definition

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (174)

Last three years. Most recent: 2026-08-27.

NumberDecision dateApplicantDevice name
K2538592026-08-27VIOL Co., Ltd.Scarlet Pro (Scarlet Pro) summary
K2525352026-08-25Taiwan Surgical CorporationInno-Switch™ Laparoscopic Instruments summary
K2611792026-07-22Gimmi GmbHAlphaTriPart - Monopolar MIC Instruments summary
K2535042026-07-13Classys, Inc.Volnewmer™ summary
K2540562026-07-01Olympus Medical Systems Corp.THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S summary
K2514922026-06-29New Deantronics Taiwan , Ltd.Irrigation Tubing Bipolar Cord Set summary
K2534842026-06-29Cynosure Lutronic Technology CorporatiLUTRONIC GENIUS summary
K2606362026-06-18Stryker Sustainability SolutionsRemanufactured LigaSure XP Maryland Jaw Sealer/Divid summary
K2536342026-06-17Hologic, Inc.CoolSeal Generator® (CSL-200-90) summary
K2618332026-06-16Neurent Medical , Ltd.NEUROMARK System (NMK00301) summary
K2531652026-06-09Sejong Medical Co., Ltd.LAP-iX2N summary
K2536562026-06-05Medtronic Sofamor Danek USA, Inc.OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Abl summary
K2539182026-06-02F Care Systems USA, LLCVeineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) summary
K2538032026-06-02Lumenis Be, Ltd.MILAN System summary
K2612022026-05-29Entire Medical , Ltd.ENTire IRE System summary
K2528332026-05-26Starmed Co., Ltd.VIVA combo RF System summary
K2531342026-05-20Lagis Enterprise Co., Ltd.LAGIS Endoscopic Instruments- Scissors (EI-330S EI-3 summary
K2605222026-05-18Aerin Medical, Inc.RhinAer+ Stylus summary
K2537772026-04-10Ascblue CorporationAscblue (8010) summary
K2539172026-04-10Plasma Surgical, Inc.ARION ARC System summary
K2604662026-04-07Zhejiang shuyou Surgical Instrument CoMultifunctional Operational Dissectors (Electrosurgi summary
K2603972026-04-06Hironic Co., Ltd.SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET ( summary
K2534052026-04-01Prana SurgicalPrana System summary
K2541222026-03-30ArthroCare CorporationFLOW FLEXTEND Wand (72290039) summary
K2602552026-03-27Aventix Medical, Inc.AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001 summary
K2536802026-03-25ArthroCare CorporationLYNX COBLATION Laryngeal Wand (72290254) summary
K2537502026-03-17BTL Industries, Inc.BTL-785NEH summary
K2524872026-03-02Gyrus Acmi, Inc.POWERSEAL Open Extended Jaw Sealer and Divider, Doub summary
K2602872026-02-24Single Pass, Inc.SP Electrocautery Device (SP20) summary
K2518132026-02-11Sutter Medizintechnik GmbHCURIS II RF Generator (REF 360100-05) summary
K2518362026-02-06Shenzhen Gsd Technology Co., Ltd.Dermatrix Duo summary
K2542902026-01-30Shenzhen Peninsula Medical GroupZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Un summary
K2514352026-01-27Inbella Medical, Inc.InbellaIgnite RF System summary
K2542202026-01-27Soniquence, LLCReusable 3 Button Fingerswitch Wand summary
K2512542026-01-15InMode , Ltd.Ignite RF System summary
K2519962026-01-14Entire Medical , Ltd.ENTire IRE System summary
K2519882026-01-12Boston Aesthetics, Inc.Boston iFace (Boston iFace) summary
K2539152025-12-18Erbe Elektromedizin GmbHMOVIVA® Hybrid Ablation Probe summary
K2527042025-11-24F Care Systems USA, LLCF Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05S summary
K2515662025-11-17Starmed Co., Ltd.TS-RF Generator (STS10) summary
K2528452025-11-06Venus Concept, Inc.Venus Nova (FP-2001) summary
K2527402025-11-04Applied Medical Resources Corp.Voyant® Open Fusion Device (EB240/Open Fusion) summary
K2524122025-10-31Applied Medical Resources CorporationVoyant® Electrosurgical Generator (EA030/Electrosurg summary
K2502752025-10-28Baylis Medical Technologies, Inc.PrecisePath™ Radiofrequency Puncture Generator and P summary
K2501262025-10-21Livsmed, Inc.ArtiSeal Vessel Sealing System - ArtiSeal Instrument summary
K2508522025-10-16Asterasys Co., Ltd.Coolfase summary
K2523672025-10-15Inbella Medical, Inc.InbellaMulti System summary
K2506882025-10-07Acotec Scientific Co., Ltd.Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-U summary
K2521502025-10-07Olympus Medical Systems CorporationUltrasonic Bipolar Generator (USG-410); Reuseable Co summary
K2518992025-10-01New Deantronics Taiwan , Ltd.E Blator summary
K2513342025-09-29Hironic Co., Ltd.NEW DOUBLO 2.0 summary
K2520432025-09-23Olympus Winter & Ibe GmbHBipolar applicator CelonProBreath (WB990310); Bipola summary
K2525762025-09-12Pollogen, Ltd.Legend X Platform summary
K2504832025-09-09Stryker InstrumentsPhotonBlade 3; PhotonBlade 3 Smoke Evacuation summary
K2502172025-09-03Agnes Medical Co., Ltd.AGNES Ultra summary
K2511082025-08-29Erbe Elektromedizin GmbHErbe ESU Model VIO® 3n with Accessories summary
K2523162025-08-19Venclose, Inc.Venclose digiRF Generator (VCRFG1); Venclose EVSRF C summary
K2437132025-08-19Agnes Medical Co., Ltd.Single Use RF Surgical Electrode (Needle Type) (AN-B summary
K2520832025-08-12Atraverse Medical, Inc.HOTWIRE™ System RF Generator and Footswitch (optiona summary
K2513272025-08-11Lutronic CorporationXERF summary
K2522112025-08-11Cnc TechnologiesDuoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH) summary
K2522152025-07-25Inbella Medical , Ltd.InbellaMAX System summary
K2500652025-07-08Jeisys Medical IncorporatedDENSITY; DENZA; DENSITY Noir summary
K2431202025-06-20Erbe Elektromedizin GmbHHybridAPC probe summary
K2512352025-06-19Baisheng Medical Co., Ltd.Electrosurgical Pads summary
K2429962025-06-10Endymed Medical, Ltd.EndyMed PRO MAX summary
K2429072025-06-06CnS Medical Co., Ltd.DELPHI System summary
K2506572025-06-03Cintron Medical Corporationgi2000 Electrosurgical Generator summary
K2512382025-05-30Maquet Cardiovascular, LLCVasoview Hemopro 3 Endoscopic Vessel Harvesting Syst summary
K2500482025-05-29Neurent Medical , Ltd.NEUROMARK System (NMK00301) summary
K2431762025-05-16Cellah Medical Co., Ltd.BLESSING System summary
K2408572025-05-15We Medical Technology (Wuxi) Co., Ltd.Youmagic FLM System (YM5-U1) summary
K2504002025-05-09Vigeon Technology Co., Ltd.Vigeon Laparoscopic Universal Smoke Evacuator (VG003 summary
K2424692025-04-25Agnes Medical Co., Ltd.RFMagik Lite summary
K2503272025-04-15Stryker InstrumentsOptaBlate Radiofrequency (RF) Generator System summary
K2427732025-04-15SterisElectro Lube NXT summary
K2434512025-03-21Erbe Elektromedizin GmbHFiAPC plus probes summary
K2422412025-03-19ShenB Co., Ltd.Sunny summary
K2439182025-02-26Maquet Cardiovascular, LLCVasoview Hemopro 3 Power Supply summary
K2418322025-02-13Boston Aesthetics, Inc.Unicorn+ RF System (Unicorn+); Unicorn+ RF System (U summary
K2502002025-02-11Inbella Medical, Inc.InbellaBody System summary
K2429832025-02-05Creo Medical, Ltd.CROMA Electrosurgical Generator (PRD-EMR-050) summary
K2500682025-02-04Venclose, Inc.Venclose digiRF Generator (VCRFG1) summary
K2403112025-01-22Compex, Spol, S.R.O.JETT Medical II summary
K2431392025-01-22Indiba S. A. U.Reverso Pro System summary
K2439292025-01-21Wontech Co., Ltd.Oligio X summary
K2430672025-01-17Ethicon Endo-Surgery, LLC (A Johnson aThe ETHICON™ Total Energy System summary
K2331182025-01-03Eunsung Global CorpDUET-V (Model: ESK-3261DV) summary
K2437372025-01-03Inbella Medical, Inc.Inbella RF System summary
K2430972024-12-26Bomtech Electronics Co., Ltd.RM STAR EX with RMS Needle summary
K2409752024-12-23Beijing Taktvoll Technology Co., Ltd.Electrosurgical Generator (ES-100); Electrosurgical summary
K2426882024-12-20Skingrab Co., Ltd.Finiff System summary
K2423702024-12-19Medline Industries, LPMedline Microdissection Needle (4cm) (140936 (ESE104 summary
K2407582024-12-11Zhejiang Curaway Medical Technology CoRadiofrequency Generator System, Cura RF Electrode summary
K2426302024-12-10Aerin Medical, Inc.Aerin Console summary
K2312162024-12-10Jeisys Medical, Inc.POTENZA summary
K2408972024-11-26VIOL Co., Ltd.Cellinew summary
K2411572024-11-21Ilooda Co,., Ltd.Secret MAX Multi-platform RF System
K2411382024-11-15Livsmed, Inc.ArtiSeal Vessel Sealing System-ArtiSeal Instruments; summary
K2422862024-11-08Guangzhou Aimira Innovation TechnologySuperflow Prime Treatment System (ASP-1M) summary
K2410992024-11-08Hironic Co., Ltd.Plasonic (Plasonic) summary
K2312872024-11-05Jeisys Medical, Inc.POTENZA summary
K2432172024-11-01Pollogen, Ltd.Legend X Desktop System summary
K2422662024-10-21Stryker InstrumentsPhotonBlade 3; PhotonBlade 3 Smoke Evacuation summary
K2422042024-09-25Dongguan Quanding Medical Supplies Co.Disposable Neutral Electrodes (GP201B-A, GP202B-A, G summary
K2415352024-09-25ShenB Co., Ltd.Vybe RF II summary
K2420442024-08-26Erbe Elektromedizin GmbHFiAPC plus probes summary
K2416352024-08-05Intuitive Surgicalda Vinci E-200 Electrosurgical Generator summary
K2409322024-08-05Erbe Elektromedizin GmbHHybridTherm System summary
K2407822024-08-05Pulse Biosciences, Inc.CellFX Percutaneous Electrode System (SYS3000); Cell summary
K2416212024-08-02Intuitive SurgicalDa Vinci Monopolar and Bipolar Adapters (378896) summary
K2407802024-07-24InMode , Ltd.InMode RF System summary
K2410852024-07-12Covidien, LLCValleylab ™FT10 Energy Platform Software Version 5.0 summary
K2336442024-07-12Megadyne Medical Products, Inc.Megadyne Patient Return Electrode Pad - Universal Du summary
K2410222024-07-11Wickimed (Huizhou) Medical Equipment MSterile single use tip cleaner (WK800-S10 , WK800-S summary
K2400702024-07-01Candela CorporationProfound Matrix summary
K2405722024-07-01Covidien, LLCValleylab™ SM Smoke Management Pencil with Edge™ Bla summary
K2331232024-06-24Hironic Co., Ltd.SILKRO summary
K2400172024-06-13InMode , Ltd.InMode System with the Morpheus8 90 Applicator summary
K2406572024-06-06Livsmed, Inc.ArtiSential Laparoscopic Instruments-Electrodes (AMH summary

54 more not listed.

Official FDA classification page: GEI
Classification and pathway per current FDA publications. Data from openFDA (CC0).