ClearanceBrief
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)
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Top companies in GEI

DateFirm and productCodeLinked 510(k)
May 18, 2016Conmed 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
GEIK140658
May 18, 2016Conmed 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
GEIK140658
May 18, 2016Conmed 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
GEIK140658
May 18, 2016Conmed 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
GEIK140658
Apr 5, 2016ArthroCare 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
GEIK080282
Jan 8, 2016ArthroCare Corporation
Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.
Terminated
GEIK063172
Dec 23, 2015DePuy Mitek, Inc., a Johnson & Johnson Co.
VAPR TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
Terminated
GEIK143475
Dec 1, 2015ConMed Corporation
Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.
Terminated
GEIK140459
Nov 3, 2015ConMed 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
GEIK140578
Sep 15, 2015Applied 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
GEIK143517
Jul 24, 2015EXP 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
GEINone listed
Jul 24, 2015EXP 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
GEINone listed
Jul 18, 2015ArthroCare 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
GEIK070374
K142999
Jun 25, 2015ArthroCare 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
GEIK142999
Jun 25, 2015ArthroCare 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
GEIK142999
Jun 24, 2015Stryker 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
GEIK041810
Jun 11, 2015Gyrus 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
GEIK123429
Jun 11, 2015Gyrus 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
GEIK123429
Mar 26, 2015ArthroCare 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
GEIK030108
Feb 24, 2015Angiodynamics
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
GEIK992693
Dec 16, 2014ArthroCare 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
GEIK083306
Dec 12, 2014Alcon 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
GEIK880863
K934320
Oct 21, 2014Gyrus 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
GEIK031078
K031081
Sep 30, 2014Instrumed 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
GEIK060232
Sep 30, 2014Instrumed 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
GEIK060232
Sep 30, 2014Instrumed 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
GEIK060232
Sep 30, 2014Instrumed 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
GEIK060232
Sep 30, 2014Instrumed 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
GEIK060232
Sep 30, 2014Instrumed 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
GEIK060232
Sep 30, 2014Instrumed 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
GEIK060232
Sep 30, 2014Instrumed 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
GEIK060232
Sep 30, 2014Instrumed 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
GEIK060232
Sep 30, 2014Instrumed 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
GEIK060232
Jul 2, 2014Microline Surgical, Inc.
Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222
Terminated
GEIK981389
Jul 2, 2014Microline Surgical, Inc.
Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221
Terminated
GEIK981389
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF 98-0033***Custom Autolube Food Guard***Rx Only*** This device is intended to be used with Anspach Systems
Terminated
GEIK940535
Jun 20, 2014ConMed 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
GEIK101534
Jun 4, 2014ConMed 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
GEIK120476
May 20, 2014Microline 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
GEIK981389
May 2, 2014Stryker 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
GEIK935237
Mar 7, 2014Megadyne 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
GEIK072559
Jan 31, 2014Medtronic 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
GEIK111285
Jan 15, 2014Teleflex 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
GEIK881413
Jan 15, 2014Teleflex 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
GEIK881413
Dec 11, 2013Aesculap, 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
GEIK952524
Dec 6, 2013Maquet 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
GEIK052274
K101274
Dec 5, 2013Olympus 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
GEIK111202
Nov 15, 2013ConMed 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
GEIK101534
Nov 15, 2013ConMed 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
GEIK101534
Nov 8, 2013Urologix, 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
GEIK113380

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