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 |
|---|---|---|---|
| Dec 10, 2024 | K242630 | Aerin Console Aerin Medical, Inc. | GEI |
| Dec 10, 2024 | K231216 | POTENZA Jeisys Medical, Inc., KR | GEI |
| Nov 26, 2024 | K240897 | Cellinew VIOL Co., Ltd., KR | GEI |
| Nov 21, 2024 | K241157 | Secret MAX Multi-platform RF System Ilooda Co,., Ltd., KR | GEI |
| Nov 15, 2024 | K241138 | ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator Livsmed, Inc., KR | GEI |
| Nov 8, 2024 | K242286 | Superflow Prime Treatment System (ASP-1M) Guangzhou Aimira Innovation Technology Co, Ltd., CN | GEI |
| Nov 8, 2024 | K241099 | Plasonic (Plasonic) Hironic Co., Ltd., KR | GEI |
| Nov 5, 2024 | K231287 | POTENZA Jeisys Medical, Inc., KR | GEI |
| Nov 1, 2024 | K243217 | Legend X Desktop System Pollogen, Ltd., IL | GEI |
| Oct 21, 2024 | K242266 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation Stryker Instruments | GEI |
| Sep 25, 2024 | K242204 | Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-P Dongguan Quanding Medical Supplies Co., Ltd., CN | GEI |
| Sep 25, 2024 | K241535 | Vybe RF II ShenB Co., Ltd., KR | GEI |
| Aug 26, 2024 | K242044 | FiAPC plus probes Erbe Elektromedizin GmbH, DE | GEI |
| Aug 5, 2024 | K241635 | da Vinci E-200 Electrosurgical Generator Intuitive Surgical | GEI |
| Aug 5, 2024 | K240932 | HybridTherm System Erbe Elektromedizin GmbH, DE | GEI |
| Aug 5, 2024 | K240782 | CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electro Pulse Biosciences, Inc. | GEI |
| Aug 2, 2024 | K241621 | Da Vinci Monopolar and Bipolar Adapters (378896) Intuitive Surgical | GEI |
| Jul 24, 2024 | K240780 | InMode RF System InMode , Ltd., IL | GEI |
| Jul 12, 2024 | K241085 | Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) Covidien, LLC | GEI |
| Jul 12, 2024 | K233644 | Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal P Megadyne Medical Products, Inc. | GEI |
| Jul 11, 2024 | K241022 | Sterile single use tip cleaner (WK800-S10 , WK800-S20) Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd, CN | GEI |
| Jul 1, 2024 | K240572 | Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m) (VSMP10); Valleylab SM Smoke Management Penc Covidien, LLC | GEI |
| Jul 1, 2024 | K240070 | Profound Matrix Candela Corporation | GEI |
| Jun 24, 2024 | K233123 | SILKRO Hironic Co., Ltd., KR | GEI |
| Jun 13, 2024 | K240017 | InMode System with the Morpheus8 90 Applicator InMode , Ltd., IL | GEI |
| Jun 6, 2024 | K240657 | ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH Livsmed, Inc., KR | GEI |
| May 31, 2024 | K241055 | Electro Lube NXT Steris | GEI |
| May 30, 2024 | K232505 | Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter Zhejiang Curaway Medical Technology Co., Ltd., CN | GEI |
| May 23, 2024 | K233120 | CWM-930S, FIXER DV9 Chungwoo Co., Ltd., KR | GEI |
| May 22, 2024 | K233099 | Gladiator Rohrer Aesthetics, LLC | GEI |
| May 8, 2024 | K241008 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003 Relign Corporation, Subsidiary of Zimmer Biomet | GEI |
| May 8, 2024 | K240999 | Legend X Applicator VO Pollogen, Ltd., IL | GEI |
| May 8, 2024 | K240964 | FLOW 90? Wand ArthroCare Corporation | GEI |
| Apr 29, 2024 | K240248 | Volnewmer Classys, Inc., KR | GEI |
| Apr 25, 2024 | K232805 | Kronos Electrocautery Device Single Pass, Inc. | GEI |
| Apr 23, 2024 | K234147 | ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); R Microline Surgical, Inc. | GEI |
| Apr 23, 2024 | K233849 | BTL-499 BTL Industries, Inc. | GEI |
| Apr 23, 2024 | K222958 | mJOULE RF System and Accessories Sciton, Inc | GEI |
| Mar 28, 2024 | K233604 | BTL-785S BTL Industries, Inc. | GEI |
| Mar 20, 2024 | K233642 | InMode RF System InMode , Ltd., IL | GEI |
| Mar 20, 2024 | K233002 | BEED 2,5, BEED 3,8 Excelsior Resources, LLC | GEI |
| Mar 14, 2024 | K232301 | Define RF Microneedling System Aesthetic Management Partners | GEI |
| Mar 8, 2024 | K233705 | CellFX Percutaneous Electrode System (SYS3000) Pulse Biosciences, Inc. | GEI |
| Mar 6, 2024 | K232703 | Disposable Bipolar Forceps Jiangsu Hope Biomedical Science & Technology Co., Ltd., CN | GEI |
| Feb 29, 2024 | K230837 | PlazMagik Agnes Medical Co., Ltd., KR | GEI |
| Feb 28, 2024 | K233830 | OsteoCool 2.0 RF Ablation System Medtronic Sofamor Danek USA, Inc. | GEI |
| Feb 27, 2024 | K233879 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Maquet Cardiovascular, LLC | GEI |
| Feb 22, 2024 | K240313 | Oligio X Wontech Co., Ltd., KR | GEI |
| Feb 16, 2024 | K231985 | Disposable Grounding Pad Shenzhen Mecun Medical Supply Co., Ltd., CN | GEI |
| Feb 9, 2024 | K232072 | AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G H.S Hospital Service S.P.A, IT | GEI |
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