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 |
|---|---|---|---|
| Aug 30, 2019 | K191732 | Sutter RaVoR Bipolar Electrodes Sutter Medizintechnik GmbH, DE | GEI |
| Aug 2, 2019 | K183112 | DiLumen Endolumenal Interventional Knife (DiLumen IK) Lumendi, LLC | GEI |
| Jul 30, 2019 | K191484 | Renuvion/J-Plasma Precise Handpiece Apyx Medical Corporation(Formerly Bovie Medical Corporation) | GEI |
| Jul 24, 2019 | K190678 | TempSure Cynosure, Inc. | GEI |
| Jul 12, 2019 | K191601 | Valleylab FT10 Electrosurgical Platform Covidien | GEI |
| Jun 25, 2019 | K190052 | Radio Frequency Ablation System Surgnova Healthcare Technologies (Zhejiang) Co., Ltd., CN | GEI |
| Jun 20, 2019 | K190336 | Soniquence Bipolar Electrodes Soniquence, LLC | GEI |
| Jun 13, 2019 | K183564 | Electrosurgical Generator Fulwell, LLC | GEI |
| Jun 12, 2019 | K191064 | Argon Handset New Deantronics Taiwan , Ltd., TW | GEI |
| Jun 12, 2019 | K190422 | Viveve System 2.0 Viveve Medical | GEI |
| May 22, 2019 | K190823 | Erbe ESU Model VIO 3 with Accessories Erbe Elektromedizin GmbH, DE | GEI |
| May 22, 2019 | K183611 | Soniquence RF Generator and Soniquence Electrodes Soniquence, LLC | GEI |
| May 8, 2019 | K183126 | Electrosurgical accessory New Deantronics Taiwan , Ltd., TW | GEI |
| May 6, 2019 | K190643 | Medline Electrocautery Pencil Medline Industries, Inc. | GEI |
| Apr 11, 2019 | K183526 | Codman Electrosurgical Generator, Foot Pedal Kls Martin GmbH + Co. KG, DE | GEI |
| Apr 4, 2019 | K183445 | Erbe APCapplicators Erbe Elektromedizin GmbH, DE | GEI |
| Mar 14, 2019 | K190168 | Aquas Probes Genicon, Inc. | GEI |
| Mar 12, 2019 | K183610 | Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpiece Bovie Medical Corporation | GEI |
| Mar 12, 2019 | K183180 | Caiman 5 Maryland Aesculap, Inc. | GEI |
| Mar 11, 2019 | K182013 | EasyInstruments Agency For Medical Innovations GmbH, AT | GEI |
| Feb 22, 2019 | K183240 | Empower RF Catheter Broncus Medical, Inc. | GEI |
| Feb 19, 2019 | K183594 | Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retracta New Deantronics Taiwan , Ltd., TW | GEI |
| Feb 12, 2019 | K190075 | Aurora Evacuator Rebound Therapeutics | GEI |
| Jan 24, 2019 | K183346 | FLOW 90 Wand ArthroCare Corporation | GEI |
| Jan 17, 2019 | K183538 | VIVA combo RF System Starmed Co., Ltd., KR | GEI |
| Jan 16, 2019 | K181071 | SIRA RFA Electrosurgical Device Innoblative Designs, Inc. | GEI |
| Jan 15, 2019 | K182497 | OsteoCool RF Ablation System Medtronic Sofamor Danek USA, Inc. | GEI |
| Dec 14, 2018 | K182354 | SafeAir Telescopic Smoke Pencil Lina Medical Aps, DK | GEI |
| Dec 13, 2018 | K180359 | BTL-FR2000 BTL Industries, Inc. | GEI |
| Dec 12, 2018 | K182812 | Medline Cautery Electrode (SILICONE) Medline Industries, Inc. | GEI |
| Dec 11, 2018 | K180999 | Mygen V-1000 RF System RF Medical Co., Ltd., KR | GEI |
| Dec 10, 2018 | K180945 | LUTRONIC GENIUS Radiofrequency System Lutronic Corporation, KR | GEI |
| Nov 29, 2018 | K182587 | Device Electrosurgical Generator ESG-150 Olympus Winter & Ibe GmbH, DE | GEI |
| Nov 27, 2018 | K182801 | Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable Integra LifeSciences Corporation | GEI |
| Nov 26, 2018 | K183009 | HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES Hemostatix Medical Technologies, LLC | GEI |
| Nov 19, 2018 | K182772 | Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil Covidien | GEI |
| Nov 14, 2018 | K182653 | Voyant Maryland Fusion Device Applied Medical Resources Corp. | GEI |
| Nov 6, 2018 | K182451 | BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider Covidien, LLC | GEI |
| Oct 24, 2018 | K182365 | TempSure System Cynosure, Inc. | GEI |
| Oct 12, 2018 | K181852 | Percuvance Percutaneous Surgical System Teleflexmedical, Inc. | GEI |
| Oct 11, 2018 | K182244 | Voyant Electrosurgical Generator Applied Medical Resources Corp. | GEI |
| Oct 11, 2018 | K180872 | SCARLET SRF VIOL Co., Ltd., KR | GEI |
| Sep 26, 2018 | K182325 | InMode RF System Inmode MD , Ltd., IL | GEI |
| Sep 20, 2018 | K182340 | NICO Myriad Nico Corporation | GEI |
| Sep 4, 2018 | K181249 | EUSRA RF Electrode Starmed Co., Ltd., KR | GEI |
| Aug 2, 2018 | K181257 | PlasmaBlade X 3.0S, PlasmaBlade X 4.0 Medtronic Advanced Energy | GEI |
| Jul 19, 2018 | K170369 | Disposable Electrosurgical Pencils Cathay Manfacturing Corp., CN | GEI |
| Jul 13, 2018 | K180654 | PINXEL-RF system Rohrer Aesthetics, LLC | GEI |
| Jul 12, 2018 | K180575 | THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 Olympus Medical Systems Corp., JP | GEI |
| Jun 21, 2018 | K181085 | LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated Covidien | GEI |
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