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 |
|---|---|---|---|
| May 27, 2020 | K200253 | Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Ethicon Endo-Surgery | GEI |
| May 22, 2020 | K191847 | Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps Adeor Medical AG, DE | GEI |
| May 21, 2020 | K192265 | gi-4000 Electrosurgical Generator United States Endoscopy Group, Inc. | GEI |
| May 14, 2020 | K200169 | VFS1 Bipolar Electrosurgical Generator FHC, Inc. | GEI |
| May 11, 2020 | K200841 | Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 Ethicon Endo-Surgery, LLC | GEI |
| May 11, 2020 | K200501 | ArtiSential Laparoscopic Instrument-Electrodes Livsmed, Inc., KR | GEI |
| May 11, 2020 | K192103 | Thunderbeat Open Fine Jaw Type X Hand Instrument Olympus Medical Systems Corp., JP | GEI |
| May 7, 2020 | K200146 | HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor Covidien, LLC | GEI |
| Apr 22, 2020 | K200185 | SYLFIRM X VIOL Co., Ltd., KR | GEI |
| Apr 20, 2020 | K200559 | CarpX Pavmed, Inc. | GEI |
| Apr 13, 2020 | K200300 | VivAer Stylus Aerin Medical, Inc. | GEI |
| Apr 8, 2020 | K200598 | Voyant Maryland Fusion Device Applied Medical Resources Corp. | GEI |
| Apr 2, 2020 | K193591 | ARC 400 Bowa-Electronics GmbH & Co. KG, DE | GEI |
| Apr 1, 2020 | K191065 | Venus VivaTM Venus Concept USA, Inc. | GEI |
| Mar 31, 2020 | K200455 | Trigger Switch and Cord New Deantronics Taiwan , Ltd., TW | GEI |
| Mar 24, 2020 | K193579 | PlasmaBlade X 3.0S LIGHT Medtronic Navigation | GEI |
| Mar 24, 2020 | K193145 | Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch Megadyne Medical Products, Inc. | GEI |
| Mar 20, 2020 | K191612 | Encision AEM Monopolar Laparoscopic Instruments and Accessories Encision Incorporated | GEI |
| Mar 6, 2020 | K192813 | Plasma IQ Neauvia North America, Inc. | GEI |
| Mar 6, 2020 | K191583 | PhotonBlade with Smoke Evacuation Invuity, Inc. | GEI |
| Mar 4, 2020 | K193019 | DANNIK Disposable Monopolar Laparoscopic Instrument Dannik | GEI |
| Mar 2, 2020 | K193356 | BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider Covidien, LLC | GEI |
| Feb 20, 2020 | K192545 | Potenza Jeisys Medical Incorporated, KR | GEI |
| Feb 13, 2020 | K190909 | ArtiSential Bipolar Fenestrated Forceps Livsmed, Inc., KR | GEI |
| Feb 10, 2020 | K193587 | Sutter Swyng non-stick bipolar forceps, single-use Sutter Medizintechnik GmbH, DE | GEI |
| Feb 4, 2020 | K183148 | OKLand Patient Return Electrode Pad Auckland Medical Polymer(Tianjin) Co., Ltd., CN | GEI |
| Jan 16, 2020 | K193611 | Viveve 2.0 System Viveve Medical, Inc. | GEI |
| Jan 15, 2020 | K183284 | INTRAcel RF Microneedle System Jeisys Medical, Inc., KR | GEI |
| Jan 7, 2020 | K192715 | CRF Radiofrequency Ablation System Cambridge Interventional, LLC | GEI |
| Dec 27, 2019 | K192695 | InMode System with the Morpheus8 (Fractora) Applicators Inmode MD , Ltd., IL | GEI |
| Dec 20, 2019 | K193292 | Voyant 5mm Fusion Device, Voyant Maryland Fusion Device Applied Medical Resources Corp. | GEI |
| Dec 20, 2019 | K193018 | Surgical Direct Hand-held Laparoscopic Instruments Surgical Direct, Inc. | GEI |
| Dec 20, 2019 | K192471 | RHIN1 Stylus Aerin Medical, Inc. | GEI |
| Dec 20, 2019 | K192027 | WEREWOLF COBLATION System, COBLATION HALO Wand ArthroCare Corporation | GEI |
| Dec 20, 2019 | K191234 | APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Erbe Elektromedizin GmbH, DE | GEI |
| Dec 19, 2019 | K193004 | Monopolar Cord New Deantronics Taiwan , Ltd., TW | GEI |
| Dec 5, 2019 | K192224 | BTL-899 Btl | GEI |
| Nov 21, 2019 | K192124 | Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories Us Medical Innovations, LLC | GEI |
| Oct 31, 2019 | K192867 | Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) Bovie Medical Corporation Dba Apyx Medical Corporation | GEI |
| Oct 28, 2019 | K182605 | HS AMICA devices family H.S Hospital Service S.P.A, IT | GEI |
| Oct 25, 2019 | K192518 | Reusable Monopolar Active Cord Us Endoscopy | GEI |
| Oct 24, 2019 | K192728 | Agnes Agnes Medical Co., Ltd., KR | GEI |
| Oct 11, 2019 | K192235 | AEON Laparoscopic Instruments Lexington Medical, Inc. | GEI |
| Oct 11, 2019 | K191542 | Apyx Plasma/RF Handpiece Bovie Medical Corporation Dba Apyx Medical Corporation | GEI |
| Oct 8, 2019 | K182773 | Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipo Faulhaber Pinzetten Ohg, DE | GEI |
| Oct 4, 2019 | K192128 | Sutter Arrowtip Monopolar Electrodes Sutter Medizintechnik GmbH, DE | GEI |
| Sep 17, 2019 | K191947 | VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Re Maquet Cardiovascular, LLC | GEI |
| Sep 13, 2019 | K191599 | NICO Myriad NOVUS Nico Corporation | GEI |
| Sep 6, 2019 | K191528 | Venus Legacy Pro Device Venus Concept USA, Inc. | GEI |
| Sep 6, 2019 | K182355 | Secret RF Smartcure Applicator with electrodes Ilooda Co,., Ltd., KR | GEI |
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