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 |
|---|---|---|---|
| Feb 28, 2008 | K071343 | ELLMAN NOBLE ALLOY ELECTRODES Ellman International, Inc. | GEI |
| Feb 25, 2008 | K073046 | ETHICON ENDO SURGERY ARTICULATING NEEDLE KNIFE, MODEL 2504 Ethicon Endo-Surgery, Inc. | GEI |
| Feb 22, 2008 | K073466 | SMITH & NEPHEW INTRADISCAL CATHETER SYSTEM Smith & Nephew, Inc. | GEI |
| Feb 15, 2008 | K080282 | ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00; Arthrocare Corp. | GEI |
| Jan 18, 2008 | K072849 | MODIFICATION TO THERMAGE THERMACOOL SYSTEM Thermage, Inc. | GEI |
| Jan 18, 2008 | K072124 | BLACK AND BLACK ELECTROSURGICAL CUTTING AND COAGULATION FORCEPS AND ELECTRODES Black & Black Surgical, Inc. | GEI |
| Jan 9, 2008 | K073687 | HABIB LAPAROSCOPIC HEXABLATE Emcision , Ltd., GB | GEI |
| Jan 9, 2008 | K073495 | TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT Tissuelink Medical, Inc. | GEI |
| Dec 28, 2007 | K072937 | OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET Olsen Medical | GEI |
| Dec 26, 2007 | K072261 | FINESSE SYSTEM Primaeva Medical, Inc. | GEI |
| Dec 19, 2007 | K073360 | PROPLATE Bio Protech, Inc. | GEI |
| Dec 19, 2007 | K072478 | BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD Baylis Medical Co., Inc., CA | GEI |
| Dec 13, 2007 | K072911 | ION MEDICAL BIPOLAR COAGULATION PEN Ion Medical, LLC | GEI |
| Oct 23, 2007 | K072865 | MODIFICATON TO: ARTHROCARE ARTHROWANDS Arthrocare Corp. | GEI |
| Oct 19, 2007 | K072789 | DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES Encision, Inc. | GEI |
| Oct 5, 2007 | K072699 | ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XL Alma Lasers , Ltd. | GEI |
| Oct 5, 2007 | K072559 | SUCTION COAGULATOR Megadyne Medical Products, Inc. | GEI |
| Oct 5, 2007 | K070443 | INTRACEPT BI-POLAR RF PROBE, MODEL 04814 Relievant Medsystems, Inc. | GEI |
| Oct 2, 2007 | K072126 | HABIB VESEAL Emcision , Ltd., GB | GEI |
| Sep 27, 2007 | K072493 | ENSEAL TISSUE SEALING DEVICE Surgrx, Inc. | GEI |
| Sep 20, 2007 | K071859 | STRYKER CROSSFIRE SYSTEM Stryker Endoscopy | GEI |
| Sep 14, 2007 | K070812 | DISPOSABLE LAPAROSCOPIC INSTRUMENT Modern Medical Equipment Mfg., Ltd. | GEI |
| Sep 12, 2007 | K072394 | PORTRAIT STAND-OFF Rhytec Incorporated | GEI |
| Sep 6, 2007 | K071976 | VECTEC DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES Vectec | GEI |
| Sep 5, 2007 | K072177 | ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM Surgrx, Inc. | GEI |
| Aug 31, 2007 | K071080 | ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M E Surgical, LLC | GEI |
| Aug 17, 2007 | K072089 | ARTHROCARE SPINEWAND Arthrocare Corp. | GEI |
| Aug 7, 2007 | K071963 | MODIFICATION TO: ARTHROCARE ARTHROWANDS Arthrocare Corp. | GEI |
| Aug 7, 2007 | K071709 | ARTHROCARE SYSTEM 12000 Arthrocare Corp. | GEI |
| Jul 26, 2007 | K071786 | PORTRAIT PSR Rhytec Incorporated | GEI |
| Jul 13, 2007 | K071728 | MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICE Surgrx, Inc. | GEI |
| Jun 29, 2007 | K071543 | HALO360' COAGULATION CATHETER Barrx Medical, Incorporated | GEI |
| Jun 27, 2007 | K071103 | HABIB HEXABLATE Emcision , Ltd., GB | GEI |
| Jun 12, 2007 | K052936 | THERMAGE THERMACOOL SYSTEM Thermage, Inc. | GEI |
| May 25, 2007 | K062171 | EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES Ortho Development Corp. | GEI |
| May 22, 2007 | K063480 | STRYKER RF INTRADISCAL ADAPTOR, MODEL 406-750 Stryker Corp. | GEI |
| May 16, 2007 | K070997 | DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX Pro-Med Instruments GmbH | GEI |
| May 16, 2007 | K062525 | REPROCESSED LIGASURE VESSEL SEALER/DIVIDER Ascent Healthcare Solutions | GEI |
| May 2, 2007 | K070446 | COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL Valleylab,A Division of Tyco Healthcare Group LP | GEI |
| Apr 27, 2007 | K063172 | ARTHROCARE CAVITY SPINEWAND Arthrocare Corp. | GEI |
| Apr 25, 2007 | K070374 | ARTHROCARE ENT PLASMA WAND Arthrocare Corp. | GEI |
| Apr 24, 2007 | K070896 | ENSEAL PTC TISSUE SEALING DEVICE Surgrx, Inc. | GEI |
| Apr 24, 2007 | K070711 | INCIRCLE BI-POLAR RF ABLATION SYSTEM Rfa Medical, Inc. | GEI |
| Apr 24, 2007 | K070311 | CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261 Medtronic Vascular | GEI |
| Apr 23, 2007 | K070958 | MODIFICATION TO ARTHROCARE ARTHROWANDS Arthrocare Corp. | GEI |
| Apr 23, 2007 | K070004 | ACCENT Alma Lasers , Ltd. | GEI |
| Apr 13, 2007 | K070851 | ARTHROCARE SPINEWANDS Arthrocare Corp. | GEI |
| Mar 9, 2007 | K070275 | FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE Rubicor Medical, Inc. | GEI |
| Mar 6, 2007 | K070162 | FORCETRIAD ELECTROSURGICAL GENERATOR; LIGASURE INSTRUMENTS Valleylab,A Division of Tyco Healthcare Group LP | GEI |
| Feb 26, 2007 | K062350 | SURGINETICS ADVANTAGEBLADE Surginetics | GEI |
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