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 |
|---|---|---|---|
| Jan 30, 2024 | K234140 | VIVA combo RF System (VIVA combo RF System) Starmed Co., Ltd., KR | GEI |
| Jan 25, 2024 | K233425 | FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) Sutter Medizintechnik GmbH, DE | GEI |
| Jan 18, 2024 | K231405 | Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non- Jiangsu Rong FU Kang Medical Instruments Co., Ltd., CN | GEI |
| Jan 8, 2024 | K233615 | Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 113 Baisheng Medical Co., Ltd., CN | GEI |
| Dec 20, 2023 | K232992 | 10THERMA Tentech, Inc., KR | GEI |
| Dec 14, 2023 | K233374 | Secret Pro Ilooda Co,., Ltd., KR | GEI |
| Dec 12, 2023 | K232947 | SIRA RFA Electrosurgical Device Innoblative Designs, Inc. | GEI |
| Dec 11, 2023 | K232290 | INTELLIO SHIFT System ArthroCare Corporation | GEI |
| Dec 5, 2023 | K231615 | Disposable Endoscopic Bipolar Jiangsu Hope Biomedical Science & Technology Co., Ltd., CN | GEI |
| Dec 1, 2023 | K230621 | LaproGlide Disposable Monopolar PTFE Coated Laparoscopic Probes Surgical Principals, Inc. | GEI |
| Nov 29, 2023 | K232033 | HYBRIDknife® flex Erbe Elektromedizin GmbH, DE | GEI |
| Nov 28, 2023 | K233493 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exofl Relign Corporation | GEI |
| Nov 20, 2023 | K233351 | Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jewelle Hg Innovations, Ltd., GB | GEI |
| Nov 20, 2023 | K233346 | Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use No Hg Innovations, Ltd., GB | GEI |
| Nov 15, 2023 | K231012 | CoolSeal Trinity Bolder Surgical, LLC | GEI |
| Oct 25, 2023 | K233147 | PiXel8-RF Rohrer Aesthetics | GEI |
| Oct 25, 2023 | K231327 | POWERSEAL Sealer and Divider Gyrus Acmi, Inc. | GEI |
| Oct 25, 2023 | K222997 | VVR Generator system Starmed Co., Ltd., KR | GEI |
| Oct 24, 2023 | K233185 | MODEL P8400 Controller for C2DXs Hemostatix Thermal Scalpel System C2dx, Inc. | GEI |
| Oct 24, 2023 | K232223 | PlaDuo System ShenB Co., Ltd., KR | GEI |
| Oct 23, 2023 | K231732 | CleanSeal Advanced Bipolar Vessel Sealer Maryland Conmed Corporation | GEI |
| Oct 19, 2023 | K231749 | Radio Frequency System Shenzhenshi Sincoheren S&T Development Co., Ltd., CN | GEI |
| Oct 17, 2023 | K232903 | Legend X Platform Pollogen, Ltd., IL | GEI |
| Oct 13, 2023 | K231495 | The Evolve System with the Transform Applicator InMode , Ltd., IL | GEI |
| Oct 12, 2023 | K232809 | Cross Vascular RF Generator and Footswitch (optional accessory) Cross Vascular, Inc. | GEI |
| Oct 12, 2023 | K230650 | Monopolar Electrode Surgical Instrument Vhmed (Nantong) Co. , Ltd., CN | GEI |
| Oct 11, 2023 | K232460 | Disposable electrosurgical pencil (MD1000) Shenzhen Mecun Medical Supply Co., Ltd., CN | GEI |
| Oct 6, 2023 | K232407 | Cautery Protective Actuation System (CPAS) Safer Surgeries Medical Devices, LLC | GEI |
| Oct 4, 2023 | K232763 | Electrode Handpieces (VCT, RFTV, BMDT series) RF Medical Co., Ltd., KR | GEI |
| Sep 21, 2023 | K230467 | BTL-899F BTL Industries, Inc. | GEI |
| Sep 8, 2023 | K231146 | AliTight Alic Iotech, LLC | GEI |
| Sep 7, 2023 | K221743 | Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes Jiangsu Bonss Medical Technology Co., Ltd., CN | GEI |
| Aug 30, 2023 | K223303 | Spinery RF Ablation System Axon Spine Medical System, IT | GEI |
| Aug 25, 2023 | K231872 | Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (2 Kirwan Surgical Products, LLC | GEI |
| Aug 18, 2023 | K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) Olympus Winter & Ibe GmbH, DE | GEI |
| Aug 14, 2023 | K230663 | Density Jeisys Medical, Inc., KR | GEI |
| Aug 11, 2023 | K223856 | NuEra Tight RF Family Bios S.R.L., IT | GEI |
| Aug 2, 2023 | K231126 | Eblator Device E Surgical, LLC | GEI |
| Jul 20, 2023 | K231790 | The InMode System with the Morpheus8 Applicators InMode , Ltd., IL | GEI |
| Jul 6, 2023 | K230968 | VYBE RF Electrosurgical System ShenB Co., Ltd., KR | GEI |
| Jun 30, 2023 | K223135 | AblatePal Radiofrequency Ablation System Compal Electronics, Inc., TW | GEI |
| Jun 26, 2023 | K230914 | ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System ( ArthroCare Corporation | GEI |
| Jun 21, 2023 | K231212 | da Vinci E-200 Electrosurgical Generator Intuitive Surgical | GEI |
| Jun 21, 2023 | K223033 | Tixel® 2 System Novoxel , Ltd., IL | GEI |
| Jun 9, 2023 | K230586 | Renuvion® Micro Handpiece Apyx Medical Corporation | GEI |
| Jun 5, 2023 | K230498 | ArtiSential Laparoscopic Instruments-Electrodes Livsmed, Inc., KR | GEI |
| May 31, 2023 | K222556 | BTL-785X BTL Industries, Inc. | GEI |
| May 30, 2023 | K230593 | Victan Jiangsu Haize Medical Scientific Development Co., Ltd., CN | GEI |
| May 18, 2023 | K230432 | Single Use Bipolar Forceps Hg Innovations, Ltd., GB | GEI |
| May 4, 2023 | K223805 | Agnes Agnes Medical Co., Ltd., KR | GEI |
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