Electrosurgical, Cutting & Coagulation & Accessories 510(k) Clearances
Product code GEI is the FDA classification for Electrosurgical, Cutting & Coagulation & Accessories, a Class 2 device regulated under 21 CFR 878.4400, reviewed by the FDA General, Plastic Surgery panel. FDA has cleared 2,312 510(k) submissions under this product code.
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).
Devices under product code GEIshare an FDA classification category, but product-code overlap does not establish the same intended use, technological characteristics, or legal predicate eligibility. Treat this list as a screening cohort and review each device's indications, labeling, substantial-equivalence summary, and current legal-marketing status.
- Cleared devices
- 2,312
- Device class
- Class 2
- Regulation
- 878.4400
- Latest clearance
Cleared devices under product code GEI
Showing the 50 most recent of 2,312 cleared devices. Clearances from 2025-09-23 to 2026-07-22.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261179 | AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH | |
| K253504 | Volnewmer™ | Classys, Inc. | |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) | Olympus Medical Systems Corp. | |
| K251492 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | |
| K253484 | LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation | |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Stryker Sustainability Solutions | |
| K253634 | CoolSeal Generator® (CSL-200-90) | Hologic, Inc. | |
| K261833 | NEUROMARK System (NMK00301) | Neurent Medical , Ltd. | |
| K253165 | LAP-iX2N | Sejong Medical Co., Ltd. | |
| K253656 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | |
| K253803 | MILAN System | Lumenis Be, Ltd. | |
| K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC | |
| K261202 | ENTire IRE System | Entire Medical , Ltd. | |
| K252833 | VIVA combo RF System | Starmed Co., Ltd. | |
| K253134 | LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) | Lagis Enterprise Co., Ltd. | |
| K260522 | RhinAer+ Stylus | Aerin Medical, Inc. | |
| K253777 | Ascblue (8010) | Ascblue Corporation | |
| K253917 | ARION ARC System | Plasma Surgical, Inc. | |
| K260466 | Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) | Zhejiang shuyou Surgical Instrument Co., Ltd. | |
| K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. | |
| K253405 | Prana System | Prana Surgical | |
| K254122 | FLOW FLEXTEND Wand (72290039) | ArthroCare Corporation | |
| K260255 | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) | Aventix Medical, Inc. | |
| K253680 | LYNX COBLATION Laryngeal Wand (72290254) | ArthroCare Corporation | |
| K253750 | BTL-785NEH | BTL Industries, Inc. | |
| K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | Gyrus Acmi, Inc. | |
| K260287 | SP Electrocautery Device (SP20) | Single Pass, Inc. | |
| K251813 | CURIS II RF Generator (REF 360100-05) | Sutter Medizintechnik GmbH | |
| K251836 | Dermatrix Duo | Shenzhen Gsd Technology Co., Ltd. | |
| K254290 | ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) | Shenzhen Peninsula Medical Group | |
| K251435 | InbellaIgnite RF System | Inbella Medical, Inc. | |
| K254220 | Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | |
| K251254 | Ignite RF System | InMode , Ltd. | |
| K251996 | ENTire IRE System | Entire Medical , Ltd. | |
| K251988 | Boston iFace (Boston iFace) | Boston Aesthetics, Inc. | |
| K253915 | MOVIVA® Hybrid Ablation Probe | Erbe Elektromedizin GmbH | |
| K252704 | F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) | F Care Systems USA, LLC | |
| K251566 | TS-RF Generator (STS10) | Starmed Co., Ltd. | |
| K252845 | Venus Nova (FP-2001) | Venus Concept, Inc. | |
| K252740 | Voyant® Open Fusion Device (EB240/Open Fusion) | Applied Medical Resources Corp. | |
| K252412 | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) | Applied Medical Resources Corporation | |
| K250275 | PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch | Baylis Medical Technologies, Inc. | |
| K250126 | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) | Livsmed, Inc. | |
| K250852 | Coolfase | Asterasys Co., Ltd. | |
| K252367 | InbellaMulti System | Inbella Medical, Inc. | |
| K250688 | Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) | Acotec Scientific Co., Ltd. | |
| K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC) | Olympus Medical Systems Corporation | |
| K251899 | E Blator | New Deantronics Taiwan , Ltd. | |
| K251334 | NEW DOUBLO 2.0 | Hironic Co., Ltd. | |
| K252043 | Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) | Olympus Winter & Ibe GmbH |
Filing a 510(k) for a Electrosurgical, Cutting & Coagulation & Accessories of this type?
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