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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2011 | Maquet Cardiovascular, LLC VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System;
Manufactured by Maquet Cardiovascular, LLC; 170 Baytech Drive, San Jose, CA 95134.
Product Usage: Endoscopic vessel harvesting systems are indi Terminated |
GEI | K052274 |
| Sep 20, 2011 | Maquet Cardiovascular, LLC VASOVIEW 7xB Endoscopic Vessel Harvesting System;
Manufactured by Maquet Cardiovascular, LLC; 170 Baytech Drive, San Jose, CA 95134.
Product Usage: Endoscopic vessel harvesting systems are indicate Terminated |
GEI | K041981 |
| Sep 20, 2011 | Maquet Cardiovascular, LLC VASOVIEW 6 Endoscopic Vessel Harvesting System
Manufactured by Maquet Cardiovascular, LLC; 170 Baytech Drive, San Jose, CA 95134.
Product Usage: Endoscopic vessel harvesting systems are indicated fo Terminated |
GEI | K041981 |
| Aug 30, 2011 | Encision, Inc. Encision AEM Suction Irrigation Electrode, Needle Tip, REF ES3885, Encision Inc., Boulder, CO 80301. Terminated |
GEI | K100711 |
| Aug 30, 2011 | Encision, Inc. Encision AEM Suction Irrigation Electrode, J-Hook,
REF ES3884.
Encision Inc.,
Boulder, CO 80301.
The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irr Terminated |
GEI | K100711 |
| Aug 30, 2011 | Encision, Inc. Encision AEM Suction Irrigation Electrode, L-Hook,
REF ES3883,
Encision Inc.,
Boulder, CO 80301.
The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and ir Terminated |
GEI | K100711 |
| Aug 30, 2011 | Encision, Inc. Encision AEM Suction Irrigation Electrode, Spatula,
REF ES3882,
Encision Inc.,
Boulder, CO 80301.
The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and i Terminated |
GEI | K100711 |
| Aug 30, 2011 | Encision, Inc. Encision AEM Suction Irrigation Electrode, L-Diamond,
REF ES3881.
Encision Inc.,
Boulder, CO 80301.
The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and Terminated |
GEI | K100711 |
| Aug 30, 2011 | Covidien, PLC Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Group LP Boulder, CO 80301.
Intended for the coagulation of soft tissue. Not intended for use in card Terminated |
GEI | K011676 |
| Aug 29, 2011 | Microline Surgical, Inc. Microline Surgical ReNew Laproscopic ControlTip Atraumatic Fenestrated Grasper Forceps Tip
Ref: 3642
The ReNew Forceps Laparoscopic Surgical Tips are intended to cut, grasp and dissect various abdomin Terminated |
GEI | K981389 |
| Aug 29, 2011 | Microline Surgical, Inc. Microline Surgical ReNew Laproscopic Long Fenestrated Grasper Forceps Tip
Ref: 3262
The ReNew Forceps Laparoscopic Surgical Tips are intended to cut, grasp and dissect various abdominal tissue for us Terminated |
GEI | K981389 |
| Aug 24, 2011 | Angiodynamics, INC Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices).
AngioDynamics, Inc.,
One Horizon Way,
Manchester, GA 30816.
Intended to be used to assist in coagulation of tissue du Terminated |
GEI | K051420 |
| Aug 24, 2011 | Angiodynamics, INC Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices).
AngioDynamics, Inc.,
One Horizon Way,
Manchester, GA 30816.
Intended to be used to assist in coagulation of tissue du Terminated |
GEI | K051420 |
| Jul 6, 2011 | Cambridge Endoscopic Devices, Incorporated Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar Cautery, 45 cm
Catalog Number:
LA1101-12
Intended for use in a variety of minimally invasive procedures to facilitate Terminated |
GEI | K061425 |
| Jul 6, 2011 | Cambridge Endoscopic Devices, Incorporated Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar Cautery, 34cm
Catalog Number:
LA1101-01
Intended for use in a variety of minimally invasive procedures to facilitate Terminated |
GEI | K061425 |
| Jul 6, 2011 | Barrx Medical, Inc. HALO Ultra Ablation Catheter:
Rx only; for use only with the Halo Flex Energy generator and accessories;
Manufactured in the USA at BRRX Medical, 540 Oakmead Parkway, Sunnyvale, CA 94085.
Product Usa Terminated |
GEI | K101111 |
| May 31, 2011 | Encision, Inc. ES0102-45, AEM Disposable Curved Scissors, 3/4", 45cm, Sterile R, Encision Inc., Boulder, CO 80301
Cutting tissue during electrosurgical procedures Terminated |
GEI | K912780 |
| May 31, 2011 | Encision, Inc. ES0101-45, AEM Disposable Curved Scissors, 1/2", 45cm, Sterile R, Encision Inc., Boulder, CO 80301
Cutting tissue during electrosurgical procedures Terminated |
GEI | K912780 |
| May 31, 2011 | Encision, Inc. ES0120, AEM Disposable Low Profile Scissors, 3/4", 35cm, Sterile R, Encision Inc., Boulder, CO 80301
Cutting tissue during electrosurgical procedures Terminated |
GEI | K912780 |
| May 31, 2011 | Encision, Inc. ES0110, AEM Disposable Hook Scissors, 35cm, Sterile R, Encision Inc., Boulder, CO 80301
Cutting tissue during electrosurgical procedures Terminated |
GEI | K912780 |
| May 31, 2011 | Encision, Inc. ES0102, AEM Disposable Curved Scissors, 3/4", 35cm, Sterile R, Encision Inc., Boulder, CO 80301
Cutting tissue during electrosurgical procedures Terminated |
GEI | K912780 |
| May 31, 2011 | Encision, Inc. ES0101, AEM Disposable Curved Scissors, 1/2", 35cm, Sterile R, Encision Inc., Boulder, CO 80301
Cutting tissue during electrosurgical procedures Terminated |
GEI | K912780 |
| Mar 17, 2011 | Stryker Endoscopy Stryker Stiletto Electrosurgical Probe (E-Probe); Model number: 0270-070-550, 0270-070-551, 0270-070-552, 0270-070-553, 0270-070-554, 0270-070-555; Manufactured by Stryker Endoscopy Puerto Rico. Terminated |
GEI | K052141 |
| Feb 17, 2011 | ConMed Electrosurgery ConMed System 2450 Electrosurgical Generator, REF 60-2450-120-69, 120V, (Refurbished), ConMed Electrosurgery, Centennial, CO.
A general-purpose electrosurgical generator used in conjunction with an el Terminated |
GEI | K052009 |
| Feb 17, 2011 | ConMed Electrosurgery ConMed System 2450 Electrosurgical Generator, REF 60-2450-230, 230V-240V, ConMed Electrosurgery, Centennial, CO.
A general-purpose electrosurgical generator used in conjunction with an electrosurgical Terminated |
GEI | K052009 |
| Feb 17, 2011 | ConMed Electrosurgery ConMed System 2450 Electrosurgical Generator, REF 60-2450-220, 220 V, ConMed Electrosurgery, Centennial, CO.
A general-purpose electrosurgical generator used in conjunction with an electrosurgical acc Terminated |
GEI | K052009 |
| Feb 17, 2011 | ConMed Electrosurgery ConMed System 2450 Electrosurgical Generator, REF 60-2450-120, 120 V, ConMed Electrosurgery, Centennial, CO.
A general-purpose electrosurgical generator used in conjunction with an electrosurgical acc Terminated |
GEI | K052009 |
| Feb 17, 2011 | ConMed Electrosurgery ConMed System 2450 Electrosurgical Generator, REF 60-2450-100, 100 V, ConMed Electrosurgery, Centennial, CO.
A general-purpose electrosurgical generator used in conjunction with an electrosurgical acc Terminated |
GEI | K052009 |
| Feb 15, 2011 | Ethicon Endo-Surgery Inc ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Product Codes: ATS45; LONG45A; 6TB45; ATG45; ATB45; ATW45; ATS45NK; and NAW45.
Intended for transection, resection, and/or creation of a Terminated |
GEI | K020779 K070887 |
| Feb 2, 2011 | Peak Surgical PEAK brand PlasmaBlade EXT, Tissue Dissection Device,
Catalogue Number: PS215-040;
Product is manufactured and distributed by PEAK Surgical, Palo Alto, CA
The PEAK Surgery System is indicated for th Terminated |
GEI | K082786 |
| Jan 25, 2011 | Sound Surgical Technologies, LLC Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies LLC, 357 South McCaslin Blvd., Suite 100, Louisville, CO 80027 Terminated |
GEI | K022051 K053510 +2 |
| Jan 25, 2011 | Covidien LP Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covidien, Valleylab, a division of Tyco Healthcare Group LP, 5920 Longbow Drive, Boulder, CO 80301
Inten Terminated |
GEI | K092879 |
| Sep 30, 2010 | Gyrus Acmi, Incorporated GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS ME Terminated |
GEI | K041285 |
| Sep 28, 2010 | Hemostatix Medical Technologies LLC MODEL P8400 HANDLE WITH INTEGRATED CABLE, FOR USE WITH MODEL P8400 CONTROLLER, REF 7013-8050, QTY (1), STERILE EO, HEMOSTATIX MEDICAL TECHNOLOGIES, LLC, BARTLETT, TN 38133 USA, CE 0473, EU REP : QFI Terminated |
GEI | K033089 K091107 +1 |
| Sep 28, 2010 | Hemostatix Medical Technologies LLC HEMOSTATIX HANDLE, FOR USE WITH MODELS 150 AND 600D HEMOSTATIX CONTROLLERS, REF 7013-5050, QTY (1), STERILE EO, HEMOSTATIX MEDICAL TECHNOLOGIES, LLC, BARTLETT, TN 38133 USA, CE 0473, EU REP : QFI LTD Terminated |
GEI | K033089 K091107 +1 |
| Sep 27, 2010 | Telefelx Medical WECK IMA/ENT Blade Electrode (1.9 cm), REF 809335, Rx Only Sterile, Teleflex Medical, RTP, NC
The blade electrode is used in a wide variety of surgical procedures. The most common uses for electrodes Terminated |
GEI | None listed |
| Aug 27, 2010 | DePuy Mitek, Inc., a Johnson & Johnson Co. Mitek VAPR Temperature Control Electrode (integrated
Product Code: 227252
The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction E Terminated |
GEI | None listed |
| Aug 27, 2010 | DePuy Mitek, Inc., a Johnson & Johnson Co. Mitek VAPR Wedge Short Electrode (integrated)
Product Code: 227213
The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrod Terminated |
GEI | None listed |
| Aug 27, 2010 | DePuy Mitek, Inc., a Johnson & Johnson Co. Mitek VAPR Wedge Electrode (integrated
Product Code: 227203
The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 Terminated |
GEI | None listed |
| Aug 27, 2010 | DePuy Mitek, Inc., a Johnson & Johnson Co. Mitek VAPR End Effect Electrode (integrated)
Product Code: 227202
The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrode Terminated |
GEI | None listed |
| Aug 27, 2010 | DePuy Mitek, Inc., a Johnson & Johnson Co. Mitek VAPR Side Effect Short Electrode (integrated)
Product Code: 227211
The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction El Terminated |
GEI | None listed |
| Aug 27, 2010 | DePuy Mitek, Inc., a Johnson & Johnson Co. Mitek VAPR Hook Electrode (integrated)
Product Code: 227305
The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 Terminated |
GEI | None listed |
| Aug 27, 2010 | DePuy Mitek, Inc., a Johnson & Johnson Co. Mitek VAPR Angled Side Effect Electrode (integrated)
Product Code: 227302
The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction E Terminated |
GEI | None listed |
| Aug 27, 2010 | DePuy Mitek, Inc., a Johnson & Johnson Co. Mitek VAPR Flexible Side Effect Electrode (integrated)
Product Code: 227312
The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Terminated |
GEI | None listed |
| Aug 27, 2010 | DePuy Mitek, Inc., a Johnson & Johnson Co. Mitek VAPR Side Effect Electrode (integrated)
Product Code: 227301
The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrod Terminated |
GEI | K082643 |
| Aug 27, 2010 | DePuy Mitek, Inc., a Johnson & Johnson Co. Mitek VAPR Premiere 90 Electrode (integrated)
Product Code: 227204
The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrod Terminated |
GEI | None listed |
| Aug 27, 2010 | DePuy Mitek, Inc., a Johnson & Johnson Co. Mitek VAPR Premiere50 Electrode (integrated)
Product Code: 227504
The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrode Terminated |
GEI | None listed |
| Aug 27, 2010 | DePuy Mitek, Inc., a Johnson & Johnson Co. Mitek VAPR S50 Knee Electrode (integrated)
Product Code: 227355
The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes Terminated |
GEI | None listed |
| Aug 27, 2010 | DePuy Mitek, Inc., a Johnson & Johnson Co. Mitek VAPR S90 Suction Electrode (integrated)
Product Code: 225370
The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrod Terminated |
GEI | None listed |
| Aug 25, 2010 | ConMed Electrosurgery ABC PROBE REF 160655 5 mm Footswitching Probe, QTY: 1 STERILE CONMED CORPORATION 525 French Rd, Utica, NY 13501 ASSEMBLED IN MEXICO
ABC PROBE REF 160655 5 mm Footswitching Probe, QTY: 10 STERILE CON Terminated |
GEI | K925903 |
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