GEI
- 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).
510(k) clearances, last 3 years (174)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K253859 | 2026-08-27 | VIOL Co., Ltd. | Scarlet Pro (Scarlet Pro) summary |
| K252535 | 2026-08-25 | Taiwan Surgical Corporation | Inno-Switch Laparoscopic Instruments summary |
| K261179 | 2026-07-22 | Gimmi GmbH | AlphaTriPart - Monopolar MIC Instruments summary |
| K253504 | 2026-07-13 | Classys, Inc. | Volnewmer summary |
| K254056 | 2026-07-01 | Olympus Medical Systems Corp. | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S summary |
| K251492 | 2026-06-29 | New Deantronics Taiwan , Ltd. | Irrigation Tubing Bipolar Cord Set summary |
| K253484 | 2026-06-29 | Cynosure Lutronic Technology Corporati | LUTRONIC GENIUS summary |
| K260636 | 2026-06-18 | Stryker Sustainability Solutions | Remanufactured LigaSure XP Maryland Jaw Sealer/Divid summary |
| K253634 | 2026-06-17 | Hologic, Inc. | CoolSeal Generator® (CSL-200-90) summary |
| K261833 | 2026-06-16 | Neurent Medical , Ltd. | NEUROMARK System (NMK00301) summary |
| K253165 | 2026-06-09 | Sejong Medical Co., Ltd. | LAP-iX2N summary |
| K253656 | 2026-06-05 | Medtronic Sofamor Danek USA, Inc. | OsteoCool RF Ablation System; OsteoCool 2.0 RF Abl summary |
| K253918 | 2026-06-02 | F Care Systems USA, LLC | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) summary |
| K253803 | 2026-06-02 | Lumenis Be, Ltd. | MILAN System summary |
| K261202 | 2026-05-29 | Entire Medical , Ltd. | ENTire IRE System summary |
| K252833 | 2026-05-26 | Starmed Co., Ltd. | VIVA combo RF System summary |
| K253134 | 2026-05-20 | Lagis Enterprise Co., Ltd. | LAGIS Endoscopic Instruments- Scissors (EI-330S EI-3 summary |
| K260522 | 2026-05-18 | Aerin Medical, Inc. | RhinAer+ Stylus summary |
| K253777 | 2026-04-10 | Ascblue Corporation | Ascblue (8010) summary |
| K253917 | 2026-04-10 | Plasma Surgical, Inc. | ARION ARC System summary |
| K260466 | 2026-04-07 | Zhejiang shuyou Surgical Instrument Co | Multifunctional Operational Dissectors (Electrosurgi summary |
| K260397 | 2026-04-06 | Hironic Co., Ltd. | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET ( summary |
| K253405 | 2026-04-01 | Prana Surgical | Prana System summary |
| K254122 | 2026-03-30 | ArthroCare Corporation | FLOW FLEXTEND Wand (72290039) summary |
| K260255 | 2026-03-27 | Aventix Medical, Inc. | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001 summary |
| K253680 | 2026-03-25 | ArthroCare Corporation | LYNX COBLATION Laryngeal Wand (72290254) summary |
| K253750 | 2026-03-17 | BTL Industries, Inc. | BTL-785NEH summary |
| K252487 | 2026-03-02 | Gyrus Acmi, Inc. | POWERSEAL Open Extended Jaw Sealer and Divider, Doub summary |
| K260287 | 2026-02-24 | Single Pass, Inc. | SP Electrocautery Device (SP20) summary |
| K251813 | 2026-02-11 | Sutter Medizintechnik GmbH | CURIS II RF Generator (REF 360100-05) summary |
| K251836 | 2026-02-06 | Shenzhen Gsd Technology Co., Ltd. | Dermatrix Duo summary |
| K254290 | 2026-01-30 | Shenzhen Peninsula Medical Group | ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Un summary |
| K251435 | 2026-01-27 | Inbella Medical, Inc. | InbellaIgnite RF System summary |
| K254220 | 2026-01-27 | Soniquence, LLC | Reusable 3 Button Fingerswitch Wand summary |
| K251254 | 2026-01-15 | InMode , Ltd. | Ignite RF System summary |
| K251996 | 2026-01-14 | Entire Medical , Ltd. | ENTire IRE System summary |
| K251988 | 2026-01-12 | Boston Aesthetics, Inc. | Boston iFace (Boston iFace) summary |
| K253915 | 2025-12-18 | Erbe Elektromedizin GmbH | MOVIVA® Hybrid Ablation Probe summary |
| K252704 | 2025-11-24 | F Care Systems USA, LLC | F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05S summary |
| K251566 | 2025-11-17 | Starmed Co., Ltd. | TS-RF Generator (STS10) summary |
| K252845 | 2025-11-06 | Venus Concept, Inc. | Venus Nova (FP-2001) summary |
| K252740 | 2025-11-04 | Applied Medical Resources Corp. | Voyant® Open Fusion Device (EB240/Open Fusion) summary |
| K252412 | 2025-10-31 | Applied Medical Resources Corporation | Voyant® Electrosurgical Generator (EA030/Electrosurg summary |
| K250275 | 2025-10-28 | Baylis Medical Technologies, Inc. | PrecisePath Radiofrequency Puncture Generator and P summary |
| K250126 | 2025-10-21 | Livsmed, Inc. | ArtiSeal Vessel Sealing System - ArtiSeal Instrument summary |
| K250852 | 2025-10-16 | Asterasys Co., Ltd. | Coolfase summary |
| K252367 | 2025-10-15 | Inbella Medical, Inc. | InbellaMulti System summary |
| K250688 | 2025-10-07 | Acotec Scientific Co., Ltd. | Cedar Endovenous Radiofrequency Catheter (ERA-C70-U summary |
| K252150 | 2025-10-07 | Olympus Medical Systems Corporation | Ultrasonic Bipolar Generator (USG-410); Reuseable Co summary |
| K251899 | 2025-10-01 | New Deantronics Taiwan , Ltd. | E Blator summary |
| K251334 | 2025-09-29 | Hironic Co., Ltd. | NEW DOUBLO 2.0 summary |
| K252043 | 2025-09-23 | Olympus Winter & Ibe GmbH | Bipolar applicator CelonProBreath (WB990310); Bipola summary |
| K252576 | 2025-09-12 | Pollogen, Ltd. | Legend X Platform summary |
| K250483 | 2025-09-09 | Stryker Instruments | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation summary |
| K250217 | 2025-09-03 | Agnes Medical Co., Ltd. | AGNES Ultra summary |
| K251108 | 2025-08-29 | Erbe Elektromedizin GmbH | Erbe ESU Model VIO® 3n with Accessories summary |
| K252316 | 2025-08-19 | Venclose, Inc. | Venclose digiRF Generator (VCRFG1); Venclose EVSRF C summary |
| K243713 | 2025-08-19 | Agnes Medical Co., Ltd. | Single Use RF Surgical Electrode (Needle Type) (AN-B summary |
| K252083 | 2025-08-12 | Atraverse Medical, Inc. | HOTWIRE System RF Generator and Footswitch (optiona summary |
| K251327 | 2025-08-11 | Lutronic Corporation | XERF summary |
| K252211 | 2025-08-11 | Cnc Technologies | Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH) summary |
| K252215 | 2025-07-25 | Inbella Medical , Ltd. | InbellaMAX System summary |
| K250065 | 2025-07-08 | Jeisys Medical Incorporated | DENSITY; DENZA; DENSITY Noir summary |
| K243120 | 2025-06-20 | Erbe Elektromedizin GmbH | HybridAPC probe summary |
| K251235 | 2025-06-19 | Baisheng Medical Co., Ltd. | Electrosurgical Pads summary |
| K242996 | 2025-06-10 | Endymed Medical, Ltd. | EndyMed PRO MAX summary |
| K242907 | 2025-06-06 | CnS Medical Co., Ltd. | DELPHI System summary |
| K250657 | 2025-06-03 | Cintron Medical Corporation | gi2000 Electrosurgical Generator summary |
| K251238 | 2025-05-30 | Maquet Cardiovascular, LLC | Vasoview Hemopro 3 Endoscopic Vessel Harvesting Syst summary |
| K250048 | 2025-05-29 | Neurent Medical , Ltd. | NEUROMARK System (NMK00301) summary |
| K243176 | 2025-05-16 | Cellah Medical Co., Ltd. | BLESSING System summary |
| K240857 | 2025-05-15 | We Medical Technology (Wuxi) Co., Ltd. | Youmagic FLM System (YM5-U1) summary |
| K250400 | 2025-05-09 | Vigeon Technology Co., Ltd. | Vigeon Laparoscopic Universal Smoke Evacuator (VG003 summary |
| K242469 | 2025-04-25 | Agnes Medical Co., Ltd. | RFMagik Lite summary |
| K250327 | 2025-04-15 | Stryker Instruments | OptaBlate Radiofrequency (RF) Generator System summary |
| K242773 | 2025-04-15 | Steris | Electro Lube NXT summary |
| K243451 | 2025-03-21 | Erbe Elektromedizin GmbH | FiAPC plus probes summary |
| K242241 | 2025-03-19 | ShenB Co., Ltd. | Sunny summary |
| K243918 | 2025-02-26 | Maquet Cardiovascular, LLC | Vasoview Hemopro 3 Power Supply summary |
| K241832 | 2025-02-13 | Boston Aesthetics, Inc. | Unicorn+ RF System (Unicorn+); Unicorn+ RF System (U summary |
| K250200 | 2025-02-11 | Inbella Medical, Inc. | InbellaBody System summary |
| K242983 | 2025-02-05 | Creo Medical, Ltd. | CROMA Electrosurgical Generator (PRD-EMR-050) summary |
| K250068 | 2025-02-04 | Venclose, Inc. | Venclose digiRF Generator (VCRFG1) summary |
| K240311 | 2025-01-22 | Compex, Spol, S.R.O. | JETT Medical II summary |
| K243139 | 2025-01-22 | Indiba S. A. U. | Reverso Pro System summary |
| K243929 | 2025-01-21 | Wontech Co., Ltd. | Oligio X summary |
| K243067 | 2025-01-17 | Ethicon Endo-Surgery, LLC (A Johnson a | The ETHICON Total Energy System summary |
| K233118 | 2025-01-03 | Eunsung Global Corp | DUET-V (Model: ESK-3261DV) summary |
| K243737 | 2025-01-03 | Inbella Medical, Inc. | Inbella RF System summary |
| K243097 | 2024-12-26 | Bomtech Electronics Co., Ltd. | RM STAR EX with RMS Needle summary |
| K240975 | 2024-12-23 | Beijing Taktvoll Technology Co., Ltd. | Electrosurgical Generator (ES-100); Electrosurgical summary |
| K242688 | 2024-12-20 | Skingrab Co., Ltd. | Finiff System summary |
| K242370 | 2024-12-19 | Medline Industries, LP | Medline Microdissection Needle (4cm) (140936 (ESE104 summary |
| K240758 | 2024-12-11 | Zhejiang Curaway Medical Technology Co | Radiofrequency Generator System, Cura RF Electrode summary |
| K242630 | 2024-12-10 | Aerin Medical, Inc. | Aerin Console summary |
| K231216 | 2024-12-10 | Jeisys Medical, Inc. | POTENZA summary |
| K240897 | 2024-11-26 | VIOL Co., Ltd. | Cellinew summary |
| K241157 | 2024-11-21 | Ilooda Co,., Ltd. | Secret MAX Multi-platform RF System |
| K241138 | 2024-11-15 | Livsmed, Inc. | ArtiSeal Vessel Sealing System-ArtiSeal Instruments; summary |
| K242286 | 2024-11-08 | Guangzhou Aimira Innovation Technology | Superflow Prime Treatment System (ASP-1M) summary |
| K241099 | 2024-11-08 | Hironic Co., Ltd. | Plasonic (Plasonic) summary |
| K231287 | 2024-11-05 | Jeisys Medical, Inc. | POTENZA summary |
| K243217 | 2024-11-01 | Pollogen, Ltd. | Legend X Desktop System summary |
| K242266 | 2024-10-21 | Stryker Instruments | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation summary |
| K242204 | 2024-09-25 | Dongguan Quanding Medical Supplies Co. | Disposable Neutral Electrodes (GP201B-A, GP202B-A, G summary |
| K241535 | 2024-09-25 | ShenB Co., Ltd. | Vybe RF II summary |
| K242044 | 2024-08-26 | Erbe Elektromedizin GmbH | FiAPC plus probes summary |
| K241635 | 2024-08-05 | Intuitive Surgical | da Vinci E-200 Electrosurgical Generator summary |
| K240932 | 2024-08-05 | Erbe Elektromedizin GmbH | HybridTherm System summary |
| K240782 | 2024-08-05 | Pulse Biosciences, Inc. | CellFX Percutaneous Electrode System (SYS3000); Cell summary |
| K241621 | 2024-08-02 | Intuitive Surgical | Da Vinci Monopolar and Bipolar Adapters (378896) summary |
| K240780 | 2024-07-24 | InMode , Ltd. | InMode RF System summary |
| K241085 | 2024-07-12 | Covidien, LLC | Valleylab FT10 Energy Platform Software Version 5.0 summary |
| K233644 | 2024-07-12 | Megadyne Medical Products, Inc. | Megadyne Patient Return Electrode Pad - Universal Du summary |
| K241022 | 2024-07-11 | Wickimed (Huizhou) Medical Equipment M | Sterile single use tip cleaner (WK800-S10 , WK800-S summary |
| K240070 | 2024-07-01 | Candela Corporation | Profound Matrix summary |
| K240572 | 2024-07-01 | Covidien, LLC | Valleylab SM Smoke Management Pencil with Edge Bla summary |
| K233123 | 2024-06-24 | Hironic Co., Ltd. | SILKRO summary |
| K240017 | 2024-06-13 | InMode , Ltd. | InMode System with the Morpheus8 90 Applicator summary |
| K240657 | 2024-06-06 | Livsmed, Inc. | ArtiSential Laparoscopic Instruments-Electrodes (AMH summary |
Official FDA classification page: GEI
Classification and pathway per current FDA publications. Data from openFDA (CC0).