Panels › General, Plastic Surgery › Product code GEI · Class 2
Electrosurgical, Cutting & Coagulation & Accessories
Regulation 878.4400
46510(k)s in 12 months (2,320 all time)
18recalls in 12 months (644 all time)
601recalls that name a 510(k)
Top companies in GEI
| Company | 510(k)s | Recalls |
|---|---|---|
| ArthroCare Corporation | 86 | 5 |
| Conmed Corporation | 25 | 53 |
| Valleylab | 69 | 0 |
| Megadyne Medical Products, Inc. | 32 | 31 |
| Covidien | 41 | 14 |
| Carefusion 2200, Inc. | 2 | 45 |
| Stryker | 9 | 35 |
| Conmedcorp | 43 | 0 |
| Gyrus Acmi, Inc. | 21 | 20 |
| Bovie Medical | 21 | 15 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 2025 | K250126 | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) Livsmed, Inc., KR | GEI |
| Oct 16, 2025 | K250852 | Coolfase Asterasys Co., Ltd., KR | GEI |
| Oct 15, 2025 | K252367 | InbellaMulti System Inbella Medical, Inc., CA | GEI |
| Oct 7, 2025 | K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mo Olympus Medical Systems Corporation, JP | GEI |
| Oct 7, 2025 | K250688 | Cedar Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar Endovenous Radiofrequency Catheter (ERA-C30-US); Endoveno Acotec Scientific Co., Ltd., CN | GEI |
| Oct 1, 2025 | K251899 | E Blator New Deantronics Taiwan , Ltd., TW | GEI |
| Sep 29, 2025 | K251334 | NEW DOUBLO 2.0 Hironic Co., Ltd., KR | GEI |
| Sep 23, 2025 | K252043 | Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator Celon Olympus Winter & Ibe GmbH, DE | GEI |
| Sep 12, 2025 | K252576 | Legend X Platform Pollogen, Ltd., IL | GEI |
| Sep 9, 2025 | K250483 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation Stryker Instruments | GEI |
| Sep 3, 2025 | K250217 | AGNES Ultra Agnes Medical Co., Ltd., KR | GEI |
| Aug 29, 2025 | K251108 | Erbe ESU Model VIO® 3n with Accessories Erbe Elektromedizin GmbH, DE | GEI |
| Aug 19, 2025 | K252316 | Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) Venclose, Inc. | GEI |
| Aug 19, 2025 | K243713 | Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F Agnes Medical Co., Ltd., KR | GEI |
| Aug 12, 2025 | K252083 | HOTWIRE System RF Generator and Footswitch (optional accessory) Atraverse Medical, Inc. | GEI |
| Aug 11, 2025 | K252211 | Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH) Cnc Technologies, KR | GEI |
| Aug 11, 2025 | K251327 | XERF Lutronic Corporation, KR | GEI |
| Jul 25, 2025 | K252215 | InbellaMAX System Inbella Medical , Ltd., CA | GEI |
| Jul 8, 2025 | K250065 | DENSITY; DENZA; DENSITY Noir Jeisys Medical Incorporated, KR | GEI |
| Jun 20, 2025 | K243120 | HybridAPC probe Erbe Elektromedizin GmbH, DE | GEI |
| Jun 19, 2025 | K251235 | Electrosurgical Pads Baisheng Medical Co., Ltd., CN | GEI |
| Jun 10, 2025 | K242996 | EndyMed PRO MAX Endymed Medical, Ltd., IL | GEI |
| Jun 6, 2025 | K242907 | DELPHI System CnS Medical Co., Ltd., KR | GEI |
| Jun 3, 2025 | K250657 | gi2000 Electrosurgical Generator Cintron Medical Corporation | GEI |
| May 30, 2025 | K251238 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Maquet Cardiovascular, LLC | GEI |
| May 29, 2025 | K250048 | NEUROMARK System (NMK00301) Neurent Medical , Ltd., IE | GEI |
| May 16, 2025 | K243176 | BLESSING System Cellah Medical Co., Ltd., KR | GEI |
| May 15, 2025 | K240857 | Youmagic FLM System (YM5-U1) We Medical Technology (Wuxi) Co., Ltd., CN | GEI |
| May 9, 2025 | K250400 | Vigeon Laparoscopic Universal Smoke Evacuator (VG003) Vigeon Technology Co., Ltd., TW | GEI |
| Apr 25, 2025 | K242469 | RFMagik Lite Agnes Medical Co., Ltd., KR | GEI |
| Apr 15, 2025 | K250327 | OptaBlate Radiofrequency (RF) Generator System Stryker Instruments | GEI |
| Apr 15, 2025 | K242773 | Electro Lube NXT Steris | GEI |
| Mar 21, 2025 | K243451 | FiAPC plus probes Erbe Elektromedizin GmbH, DE | GEI |
| Mar 19, 2025 | K242241 | Sunny ShenB Co., Ltd., KR | GEI |
| Feb 26, 2025 | K243918 | Vasoview Hemopro 3 Power Supply Maquet Cardiovascular, LLC | GEI |
| Feb 13, 2025 | K241832 | Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Un Boston Aesthetics, Inc. | GEI |
| Feb 11, 2025 | K250200 | InbellaBody System Inbella Medical, Inc., CA | GEI |
| Feb 5, 2025 | K242983 | CROMA Electrosurgical Generator (PRD-EMR-050) Creo Medical, Ltd., GB | GEI |
| Feb 4, 2025 | K250068 | Venclose digiRF Generator (VCRFG1) Venclose, Inc. | GEI |
| Jan 22, 2025 | K243139 | Reverso Pro System Indiba S. A. U., ES | GEI |
| Jan 22, 2025 | K240311 | JETT Medical II Compex, Spol, S.R.O., CZ | GEI |
| Jan 21, 2025 | K243929 | Oligio X Wontech Co., Ltd., KR | GEI |
| Jan 17, 2025 | K243067 | The ETHICON Total Energy System Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company) | GEI |
| Jan 3, 2025 | K243737 | Inbella RF System Inbella Medical, Inc., CA | GEI |
| Jan 3, 2025 | K233118 | DUET-V (Model: ESK-3261DV) Eunsung Global Corp, KR | GEI |
| Dec 26, 2024 | K243097 | RM STAR EX with RMS Needle Bomtech Electronics Co., Ltd., KR | GEI |
| Dec 23, 2024 | K240975 | Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) Beijing Taktvoll Technology Co., Ltd., CN | GEI |
| Dec 20, 2024 | K242688 | Finiff System Skingrab Co., Ltd., KR | GEI |
| Dec 19, 2024 | K242370 | Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) Medline Industries, LP | GEI |
| Dec 11, 2024 | K240758 | Radiofrequency Generator System, Cura RF Electrode Zhejiang Curaway Medical Technology Co., Ltd., CN | GEI |
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