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 |
|---|---|---|---|
| Apr 27, 2023 | K230547 | PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Conmed Corporation | GEI |
| Apr 27, 2023 | K230539 | ArtiSential Laparoscopic Instruments-Electrodes Livsmed, Inc., KR | GEI |
| Apr 27, 2023 | K230272 | Renuvion® APR Handpiece Apyx Medical Corporation | GEI |
| Apr 26, 2023 | K230499 | ArtiSential Laparoscopic Instruments-Electrodes Livsmed, Inc., KR | GEI |
| Apr 26, 2023 | K223932 | SafeAir combi (SFR-combi-US) Lina Medical Aps, DK | GEI |
| Apr 18, 2023 | K223784 | Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 Deltronix Equipamentos Ltda, BR | GEI |
| Apr 13, 2023 | K230387 | ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSL Ethicon Endo-Surgery, LLC | GEI |
| Mar 28, 2023 | K230255 | Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 Stryker Sustainability Solutions | GEI |
| Mar 23, 2023 | K223488 | ClosureFast Endovenous Radiofrequency Ablation Catheter Medtronic, Inc. | GEI |
| Mar 22, 2023 | K230194 | HF Surgery Generator 400KHZ Richard Wolf Medical Instruments Corporation | GEI |
| Mar 21, 2023 | K222709 | Retraction, CWM-910T, APOLEX Tite Chungwoo Co., Ltd., KR | GEI |
| Mar 20, 2023 | K220725 | HPR45i F Care Systems USA, LLC | GEI |
| Feb 23, 2023 | K223262 | Renuvion® APR Handpiece Apyx Medical Corporation | GEI |
| Feb 9, 2023 | K220505 | ATTIVA Italian Engineering S.R.L., IT | GEI |
| Feb 3, 2023 | K220996 | Duoblade Cnc Technologies, KR | GEI |
| Jan 23, 2023 | K223158 | LigaSure XP Maryland Jaw Sealer/Divider Covidien, LLC | GEI |
| Jan 19, 2023 | K221522 | HF-cables (resusable) Olympus Winter & Ibe GmbH, DE | GEI |
| Jan 17, 2023 | K223222 | Plasma IQ Neauvia North America, Inc. | GEI |
| Jan 12, 2023 | K221873 | NeoGen PSR System Energist Limited, GB | GEI |
| Nov 28, 2022 | K223039 | da Vinci E-200 Electrosurgical Generator Intuitive Surgical | GEI |
| Nov 23, 2022 | K223292 | TempSure System Cynosure, LLC | GEI |
| Nov 23, 2022 | K221815 | Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, Baisheng Medical Co., Ltd., CN | GEI |
| Nov 17, 2022 | K213042 | Supra Non-Stick Bipolar Forceps Guenter Bissinger Medizintechnik GmbH, DE | GEI |
| Nov 3, 2022 | K223110 | truSculpt iD Cutera, Inc. | GEI |
| Oct 26, 2022 | K222032 | NEUROMARK System Neurent Medical, IE | GEI |
| Oct 17, 2022 | K222793 | WavelinQ Generator C.R. Bard, Inc. | GEI |
| Oct 16, 2022 | K221574 | LUDWIG Electrosurgical Device Aesthetics Biomedical | GEI |
| Oct 14, 2022 | K222284 | Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) Applied Medical Resources Corporation | GEI |
| Oct 13, 2022 | K221989 | The Oligio Wontech Co., Ltd., KR | GEI |
| Oct 11, 2022 | K221830 | Apyx One Console Apyx Medical Corporation | GEI |
| Oct 7, 2022 | K213610 | Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper For Katalyst Surgical, LLC | GEI |
| Oct 5, 2022 | K220138 | Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP Led Spa, IT | GEI |
| Sep 27, 2022 | K212561 | MTX-C1 Ilooda Co,., Ltd., KR | GEI |
| Sep 22, 2022 | K213674 | CellFX System Pulse Biosciences, Inc. | GEI |
| Sep 16, 2022 | K221074 | OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device Stryker Corporation | GEI |
| Sep 9, 2022 | K222429 | Ellusa Reusable Bipolar Cable Ellusa, LLC | GEI |
| Sep 8, 2022 | K222425 | Ellusa Reusable Neutral Plates Ellusa, LLC | GEI |
| Sep 2, 2022 | K222075 | CellFX System Pulse Biosciences, Inc. | GEI |
| Sep 2, 2022 | K221277 | Mygen M-3004 RF Generator M-3004 RF Medical Co., Ltd., KR | GEI |
| Sep 2, 2022 | K212222 | Soniquence Reusable 3 Button Fingerswitch Wand Soniquence, LLC | GEI |
| Sep 1, 2022 | K220563 | Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ C ArthroCare Corporation | GEI |
| Aug 26, 2022 | K214058 | Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer Conmed Corporation | GEI |
| Aug 1, 2022 | K221671 | CellFX® System Pulse Biosciences, Inc. | GEI |
| Jul 29, 2022 | K221907 | RhinAer® Stylus (FG1393) Aerin Medical, Inc. | GEI |
| Jul 28, 2022 | K221945 | Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Bea Conmed Corporation | GEI |
| Jul 15, 2022 | K220970 | Renuvion APR Handpiece Apyx Medical Corporation(Formerly Bovie Medical Corporation) | GEI |
| Jul 14, 2022 | K203013 | AGNES Agnes Medical Co., Ltd., KR | GEI |
| Jul 13, 2022 | K221407 | truSculpt iD Cutera, Inc. | GEI |
| Jul 7, 2022 | K212472 | AgeJet Triworks Group Srl, IT | GEI |
| Jun 27, 2022 | K213786 | CiRX Single use electrosurgical pencil with non-coated and coated electrode Ningbo Shun YE Medical Company, Ltd., CN | GEI |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.