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) |
|---|---|---|---|
| May 18, 2016 | Conmed Corporation Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC generators or conv Terminated |
GEI | K140658 |
| May 18, 2016 | Conmed Corporation Pediatric ThermoGard Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710.
Intended to be used for the dispersion and return to the electrosurgical generator. Terminated |
GEI | K140658 |
| May 18, 2016 | Conmed Corporation Adult ThermoGard Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410.
Intended to be used for the dispersion and return to the electrosurgical generator. Terminated |
GEI | K140658 |
| May 18, 2016 | Conmed Corporation Adult ThermoGard Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310.
Intended to be used for the dispersion and return to the electrosurgical generator. Terminated |
GEI | K140658 |
| Apr 5, 2016 | ArthroCare Corporation TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01 Terminated |
GEI | K080282 |
| Jan 8, 2016 | ArthroCare Corporation Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures. Terminated |
GEI | K063172 |
| Dec 23, 2015 | DePuy Mitek, Inc., a Johnson & Johnson Co. VAPR TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028) Terminated |
GEI | K143475 |
| Dec 1, 2015 | ConMed Corporation Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source. Terminated |
GEI | K140459 |
| Nov 3, 2015 | ConMed Corporation Arthroscopic Energy 50 Probe with Suction, Catalog number: AES-50S
Peoduct Usage:
For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedi Terminated |
GEI | K140578 |
| Sep 15, 2015 | Applied Medical Resources Corp Voyant Open Fusion Device
Models: EB040 and EB040+
Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipol Terminated |
GEI | K143517 |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange FIBERWIRE SUTURE SCISSOR;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number AR-11796;
EXP (repackager), Arrow (OEM)
Electrosurgical, cutting & coagulation &
ac Terminated |
GEI | None listed |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange -Suction Coagulator;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number E2505-10FR;
EXP (repackager), Valleylab (OEM)
Electrosurgical, cutting & coagulation & Terminated |
GEI | None listed |
| Jul 18, 2015 | ArthroCare Corporation EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable
Product Usage:
PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of Terminated |
GEI | K070374 K142999 |
| Jun 25, 2015 | ArthroCare Medical Corporation PROcise XP Wand with Integrated Cable REF EICA8872-01
Product Usage:
PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorh Terminated |
GEI | K142999 |
| Jun 25, 2015 | ArthroCare Medical Corporation EVAC 70 XTRA with Integrated Cable REF EICA5872-01
Product Usage:
PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhino Terminated |
GEI | K142999 |
| Jun 24, 2015 | Stryker Endoscopy SERFAS 90 degree Energy Probe, Part Number 279-350-101;
SERFAS Energy Probes are indicated for arthroscopic procedures of the knee, shoulder, ankle, hip, elbow and wrist. Specifically, the probes are Terminated |
GEI | K041810 |
| Jun 11, 2015 | Gyrus Acmi, Incorporated Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and H Terminated |
GEI | K123429 |
| Jun 11, 2015 | Gyrus Acmi, Incorporated Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and H Terminated |
GEI | K123429 |
| Mar 26, 2015 | ArthroCare Medical Corporation Coblator II System, 120V.
Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surgery. The system consis Terminated |
GEI | K030108 |
| Feb 24, 2015 | Angiodynamics Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615; and 25c Terminated |
GEI | K992693 |
| Dec 16, 2014 | ArthroCare Medical Corporation Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches.
The Wands are indicated for the resec Terminated |
GEI | K083306 |
| Dec 12, 2014 | Alcon Research, Ltd. Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument f Terminated |
GEI | K880863 K934320 |
| Oct 21, 2014 | Gyrus Medical, Inc GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm
REF 3345PK - PKS MOLly Forceps 5mm/45cm
REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm
REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm
REF 3 Terminated |
GEI | K031078 K031081 |
| Sep 30, 2014 | Instrumed International, Inc. Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provi Terminated |
GEI | K060232 |
| Sep 30, 2014 | Instrumed International, Inc. Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provi Terminated |
GEI | K060232 |
| Sep 30, 2014 | Instrumed International, Inc. Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provi Terminated |
GEI | K060232 |
| Sep 30, 2014 | Instrumed International, Inc. Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provi Terminated |
GEI | K060232 |
| Sep 30, 2014 | Instrumed International, Inc. Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provi Terminated |
GEI | K060232 |
| Sep 30, 2014 | Instrumed International, Inc. Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provi Terminated |
GEI | K060232 |
| Sep 30, 2014 | Instrumed International, Inc. Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provi Terminated |
GEI | K060232 |
| Sep 30, 2014 | Instrumed International, Inc. Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provi Terminated |
GEI | K060232 |
| Sep 30, 2014 | Instrumed International, Inc. Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provi Terminated |
GEI | K060232 |
| Sep 30, 2014 | Instrumed International, Inc. Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provi Terminated |
GEI | K060232 |
| Jul 2, 2014 | Microline Surgical, Inc. Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable)
Ref 3222 Terminated |
GEI | K981389 |
| Jul 2, 2014 | Microline Surgical, Inc. Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips
Ref 3221 Terminated |
GEI | K981389 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0033***Custom Autolube Food Guard***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
GEI | K940535 |
| Jun 20, 2014 | ConMed Corporation Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm Catalog Number: 60-9511-001, 3) 10 mm x 36 cm Catalog Number: Terminated |
GEI | K101534 |
| Jun 4, 2014 | ConMed Corporation MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient Terminated |
GEI | K120476 |
| May 20, 2014 | Microline Surgical Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222
The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue f Terminated |
GEI | K981389 |
| May 2, 2014 | Stryker Endoscopy 12-Instrument Sterilization Tray;
Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Con Terminated |
GEI | K935237 |
| Mar 7, 2014 | Megadyne Medical Products, Inc. Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek polyester peel pouch, 25 pouches per box.
This device is intended to conduc Terminated |
GEI | K072559 |
| Jan 31, 2014 | Medtronic Advanced Energy, LLC Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories)
The Aquamantys3 System combines radio frequency Terminated |
GEI | K111285 |
| Jan 15, 2014 | Teleflex Medical Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 27709.
Intended to remove tissue and control bleeding by use of high-frequen Terminated |
GEI | K881413 |
| Jan 15, 2014 | Teleflex Medical Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 2770.
Intended to remove tissue and control bleeding by use of high-frequenc Terminated |
GEI | K881413 |
| Dec 11, 2013 | Aesculap, Inc. Aesculap GNI161 Bipolar Foot Control
Product Usage:
The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used i Terminated |
GEI | K952524 |
| Dec 6, 2013 | Maquet Cardiovascular, LLC Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470
Indicated for use in minimally invasive surgery allowing access for vessel harves Terminated |
GEI | K052274 K101274 |
| Dec 5, 2013 | Olympus America Inc. TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-05 Terminated |
GEI | K111202 |
| Nov 15, 2013 | ConMed Corporation ALTRUS THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaft, REF 60-9522-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus Thermal Tissue Fusio Terminated |
GEI | K101534 |
| Nov 15, 2013 | ConMed Corporation ALTRUS THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft, REF 60-9520-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus Thermal Tissue Fusio Terminated |
GEI | K101534 |
| Nov 8, 2013 | Urologix, Inc. Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide.
The Prostiva RF Model 8929 Hand Piece Kit is the delivery system component of the Prostiva RF Therapy System. P Terminated |
GEI | K113380 |
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