Panels › General, Plastic Surgery › Product code GEI · Class 2
Electrosurgical, Cutting & Coagulation & Accessories
Regulation 878.4400
47510(k)s in 12 months (2,321 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 11, 2017 | K170990 | Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator Spiration, Inc. | GEI |
| May 8, 2017 | K171094 | Thermi Reusable Non-invasive RF Electrode Thermgen, L.L.C | GEI |
| May 4, 2017 | K163615 | Snowden-Pencer MicroLap 3mm Laparoscopic Instruments Carefusion 2200, Inc. | GEI |
| May 3, 2017 | K170107 | Surgi Max Ultra Elliquence, LLC | GEI |
| May 1, 2017 | K170777 | Bovie J-Plasma Precise FLEX Handpiece Bovie Medical Corporation | GEI |
| Apr 21, 2017 | K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated Covidien | GEI |
| Apr 21, 2017 | K170721 | Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil Precision Surgical, LLC | GEI |
| Apr 21, 2017 | K170358 | joimax Endovapor 2 Joimax GmbH, DE | GEI |
| Apr 20, 2017 | K163415 | SlimShape System Syneron Medical, Ltd., IL | GEI |
| Apr 14, 2017 | K170582 | Saf-T-Vac Smoke and Fluid Evacuator Surgical Technology Laboratories, Inc. | GEI |
| Apr 13, 2017 | K170610 | PlasmaBlade T Medtronic Advanced Energy | GEI |
| Apr 5, 2017 | K170377 | TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM Richard Wolf Medical Instruments Corporation | GEI |
| Mar 29, 2017 | K170161 | New Deantronics E Green Electrosurgical Monopolar Pencils New Deantronics Taiwan , Ltd., TW | GEI |
| Mar 20, 2017 | K170296 | CoreCath 2.7S Medtronic Advanced Energy | GEI |
| Mar 13, 2017 | K170116 | Thermi Injectable RF Electrodes Thermi | GEI |
| Mar 8, 2017 | K170188 | Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator Bovie Medical Corporation | GEI |
| Mar 8, 2017 | K163450 | VIVA combo RF System Starmed Co., Ltd., KR | GEI |
| Feb 28, 2017 | K170105 | Jac-Cell Medic testers Jac-Cell Medic, CA | GEI |
| Feb 16, 2017 | K170170 | Valleylab FT10 Electrosurgical Platform Covidien, LLC | GEI |
| Feb 14, 2017 | K163548 | ENSEAL X1 Large Jaw Tissue Sealer Ethicon Endo-Surgery, LLC | GEI |
| Jan 31, 2017 | K161949 | OsteoCool V-3 RF Ablation System Baylis Medical Company, Inc., CA | GEI |
| Jan 30, 2017 | K162034 | OBS Electrosurgical Generator (Model: OBS-350A) Baisheng Medical Co., Ltd., CN | GEI |
| Jan 24, 2017 | K162802 | Barrx Anorectal RFA Wand Covidien, LLC | GEI |
| Jan 11, 2017 | K162810 | InSeca ARC Stylus, Aerin Console Aerin Medical, Inc. | GEI |
| Jan 6, 2017 | K162490 | Disc-FX System Elliquence, LLC | GEI |
| Jan 5, 2017 | K160469 | AGNES Gowoonsesang Cosmetics Co., Ltd., KR | GEI |
| Jan 4, 2017 | K162770 | Relign System Relign Corporation | GEI |
| Dec 21, 2016 | K161307 | NICO Myriad Nico Corporation | GEI |
| Dec 12, 2016 | K163373 | PK AIM Gyrus Acmi, Inc. | GEI |
| Dec 12, 2016 | K163190 | InMode RF System Inmode MD , Ltd., IL | GEI |
| Dec 1, 2016 | K163106 | CODMAN Integrated Bipolar Cord and Tubing Set Medos International SARL, CH | GEI |
| Dec 1, 2016 | K162676 | Voyant Open Fusion Device Applied Medical Resources | GEI |
| Nov 14, 2016 | K162941 | Ligasure Blunt Tip, Sealer/Divider, Nano-coated Covidien | GEI |
| Nov 10, 2016 | K162656 | ESU-1 Electrosurgical Generator Tva Medical, Inc. | GEI |
| Nov 2, 2016 | K161378 | joimax Electrosurgical Instruments Joimax GmbH, DE | GEI |
| Oct 26, 2016 | K162469 | CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps Medos International SARL, CH | GEI |
| Oct 21, 2016 | K161481 | Ambient HipVac 50 Wand with Integrated Finger Switches ArthroCare Corporation | GEI |
| Oct 19, 2016 | K160706 | ReNew V Handpiece Laparoscopic Instruments Microline Surgical, Inc. | GEI |
| Oct 12, 2016 | K160103 | Spetzler Malis Dual Illuminating Bipolar Forceps Synergetics | GEI |
| Oct 7, 2016 | K161038 | PK Morcellator Gyrus Acmi, Inc. | GEI |
| Oct 6, 2016 | K162547 | Viveve System Viveve, Inc. | GEI |
| Sep 29, 2016 | K162126 | Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW) ArthroCare Corporation | GEI |
| Sep 26, 2016 | K161825 | PK AIM Gyrus Acmi, Inc. | GEI |
| Sep 22, 2016 | K161994 | Aerin Medical Stylus Aerin Medical, Inc. | GEI |
| Sep 16, 2016 | K161804 | LigaSure Retractable L-Hook Laparoscopic Sealer/Divider Covidien | GEI |
| Sep 15, 2016 | K162053 | PhotonBlade Invuity, Inc. | GEI |
| Sep 15, 2016 | K162047 | LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated Covidien | GEI |
| Sep 9, 2016 | K161581 | Arthrex Synergy RF System Arthrex, Inc. | GEI |
| Sep 9, 2016 | K160754 | Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) Venclose, Inc. | GEI |
| Sep 9, 2016 | K160554 | Enseal X1 Large Jaw Tissue Sealer Ethicon Endo-Surgery, LLC | GEI |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.