Electrosurgical, Cutting & Coagulation & Accessories

Device Code: 5648

Product Code(s): GEI

Definition: Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 FR 26807, Available At Https:/

Device Classification Information

Device Type ID5648
Device NameElectrosurgical, Cutting & Coagulation & Accessories
Regulation DescriptionElectrosurgical Cutting And Coagulation Device And Accessories.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch Two - Surgical (GSDB2)
Submission Type510(k)
CFR Regulation Number878.4400 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGEI
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID5648
DeviceElectrosurgical, Cutting & Coagulation & Accessories
Product CodeGEI
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionElectrosurgical Cutting And Coagulation Device And Accessories.
CFR Regulation Number878.4400 [🔎]
Premarket Reviews
ManufacturerDecision
AERIN MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
AESCULAP
 
SUBSTANTIALLY EQUIVALENT
 4
AESCULAP, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
AGENCY FOR MEDICAL INNOVATIONS GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
APPLIED MEDICAL RESOURCES
 
SUBSTANTIALLY EQUIVALENT
 13
APPLIED MEDICAL RESOURCES CORP.
 
SUBSTANTIALLY EQUIVALENT
 13
ARTHREX, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ARTHROCARE CORP.
 
SUBSTANTIALLY EQUIVALENT
 9
BAISHENG MEDICAL CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 1
BAYLIS MEDICAL COMPANY INC.
 
SUBSTANTIALLY EQUIVALENT
 3
BIO PROTECH, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
BOSTON SCIENTIFIC CORP.
 
SUBSTANTIALLY EQUIVALENT
 1
BOSTON SCIENTIFIC CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
BOVIE MEDICAL CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 10
BTL INDUSTRIES LTD
 
SUBSTANTIALLY EQUIVALENT
 3
CARDINAL HEALTH 200, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
CONMED
 
SUBSTANTIALLY EQUIVALENT
 7
CONMED CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 7
COVIDIEN
 
SUBSTANTIALLY EQUIVALENT
 18
COVIDIEN IIC
 
SUBSTANTIALLY EQUIVALENT
 1
COVIDIEN LLC
 
SUBSTANTIALLY EQUIVALENT
 8
COVIDIEN, LLC
 
SUBSTANTIALLY EQUIVALENT
 2
DEPUY INTL., LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
 
SUBSTANTIALLY EQUIVALENT
 2
DOMAIN SURGICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
ELETTRONICA VALSERIANA SRL
 
SUBSTANTIALLY EQUIVALENT
 1
ELLIQUENCE LLC
 
SUBSTANTIALLY EQUIVALENT
 2
EMCISION, LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
ENCISION INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ENCISION, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ENT BIOTECH SOLUTIONS
 
SUBSTANTIALLY EQUIVALENT
 1
ERBE ELEKTROMEDIZIN GMBH
 
SUBSTANTIALLY EQUIVALENT
 2
ERBE USA, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ETHICON
 
SUBSTANTIALLY EQUIVALENT
 7
ETHICON ENDO-SURGERY, LLC
 
SUBSTANTIALLY EQUIVALENT
 7
GUENTER BISSINGER MEDIZINTECHNIK GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
GUNTER BISSINGER MEDIZINTECHNIK GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
GYRUS ACMI INC.
 
SUBSTANTIALLY EQUIVALENT
 5
GYRUS ACMI, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
HEMOSTATIX MEDICAL TECHNOLOGIES, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
HET SYSTEMS,LLC
 
SUBSTANTIALLY EQUIVALENT
 1
I.C. MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
IMEDICOM CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
INMODE MD LTD.
 
SUBSTANTIALLY EQUIVALENT
 7
INTEGRA
 
SUBSTANTIALLY EQUIVALENT
 1
INTEGRA LIFESCIENCES CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
INTUITIVE SURGICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
INVUITY INC.
 
SUBSTANTIALLY EQUIVALENT
 1
JAC-CELL MEDIC, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
JEISYS MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
JOIMAX GMBH
 
SUBSTANTIALLY EQUIVALENT
 2
KARL STORZ GMBH & CO. KG
 
SUBSTANTIALLY EQUIVALENT
 2
KARL STORZ SE & CO KG
 
SUBSTANTIALLY EQUIVALENT
 1
KEY SURGICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
LEONHARD LANG GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
LIGER MEDICAL, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
LINA MEDICAL APS
 
SUBSTANTIALLY EQUIVALENT
 4
LOKTAL MEDICAL ELECTRONICS IND. COM. LTDA- EPP
 
SUBSTANTIALLY EQUIVALENT
 1
LUMENDI, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
LUTRONIC CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
LUTRONIC, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MAQUET CARDIOVASCULAR, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
MAQUET, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MEDAGENT, INC
 
SUBSTANTIALLY EQUIVALENT
 1
MEDERI THERAPEUTICS INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MEDLINE
 
SUBSTANTIALLY EQUIVALENT
 2
MEDLINE INDUSTRIES, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
MEDOS INTERNATIONAL SARL
 
SUBSTANTIALLY EQUIVALENT
 2
MEDTRONIC INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MEDTRONIC, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MEGADYNE MEDICAL PRODUCTS, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
MICROLINE SURGICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED
 
SUBSTANTIALLY EQUIVALENT
 3
NEW DEANTRONICS TAIWAN, LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
NICO CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 4
OLYMPUS
 
SUBSTANTIALLY EQUIVALENT
 7
OLYMPUS CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 11
OLYMPUS MEDICAL SYSTEMS CORP.
 
SUBSTANTIALLY EQUIVALENT
 4
OVESCO ENDOSCOPY
 
SUBSTANTIALLY EQUIVALENT
 1
POLLOGEN LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
PRECISION SURGICAL, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
PURPLE SURGICAL INTERNATIONAL LIMITED
 
SUBSTANTIALLY EQUIVALENT
 1
QINGDAO KINGSTON MEDICAL DEVICES LTD
 
SUBSTANTIALLY EQUIVALENT
 1
RELIGN CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
RICHARD WOLF
 
SUBSTANTIALLY EQUIVALENT
 1
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
ROHRER AESTHETICS, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
SAPHENA MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SMITH & NEPHEW, INC.
 
SUBSTANTIALLY EQUIVALENT
 9
SOLTA MEDICAL
 
SUBSTANTIALLY EQUIVALENT
 2
SPIRATION, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
STERIS CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
STRYKER
 
SUBSTANTIALLY EQUIVALENT
 1
STRYKER CORP.
 
SUBSTANTIALLY EQUIVALENT
 6
STRYKER CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 3
SUTTER MEDIZINTECHNIK GMBH
 
SUBSTANTIALLY EQUIVALENT
 2
SYNERON
 
SUBSTANTIALLY EQUIVALENT
 2
SYNERON MEDICAL LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
TELEA ELECTRONIC ENGINEERING SRL
 
SUBSTANTIALLY EQUIVALENT
 2
TELEFLEX MEDICAL
 
SUBSTANTIALLY EQUIVALENT
 2
TELEFLEX MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
TERUMO CARDIOVASCULAR SYSTEMS
 
SUBSTANTIALLY EQUIVALENT
 2
TERUMO CARDIOVASCULAR SYSTEMS CORP.
 
SUBSTANTIALLY EQUIVALENT
 2
THERMI
 
SUBSTANTIALLY EQUIVALENT
 2
U & I CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
UROLOGIX
 
SUBSTANTIALLY EQUIVALENT
 1
UROLOGIX, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
VENCLOSE, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
VENUS CONCEPT LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
VENUS CONCEPT USA INC.
 
SUBSTANTIALLY EQUIVALENT
 1
VIOL CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
VIORA LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Break
 5124
Pad
 1849
Adverse Event Without Identified Device Or Use Problem
 1349
Probe
 932
Energy Output To Patient Tissue Incorrect
 844
Difficult To Open Or Close
 677
Detachment Of Device Component
 652
Peeled / Delaminated
 521
Insulation
 478
Device Operates Differently Than Expected
 432
Sparking
 383
Device Displays Incorrect Message
330
Melted
 319
Detachment Of Device Or Device Component
 298
Fire
 294
Energy Output Problem
293
Insufficient Information
 280
Self-Activation Or Keying
270
Material Deformation
 257
Material Fragmentation
 241
Device Remains Activated
 227
Sticking
 218
Tip
 202
Output Problem
 196
Arcing
 186
Temperature Problem
 184
Jaw
 177
Suction Failure
 164
Failure To Cut
 157
Bent
 149
Mechanical Jam
 142
Use Of Device Problem
 141
Leak / Splash
 139
Thermal Decomposition Of Device
 138
Flare Or Flash
 135
Retraction Problem
 132
Mechanical Problem
 128
Failure To Deliver Energy
124
Electrical /Electronic Property Problem
 119
Arcing Of Electrodes
 105
Wire
 99
Entrapment Of Device
 95
Delivered As Unsterile Product
 94
Material Separation
 91
Balloon
 86
Device Stops Intermittently
 85
Burst Container Or Vessel
78
Smoking
 77
Overheating Of Device
 77
Electrode
 76
Suction Problem
 73
No Apparent Adverse Event
 71
Component Missing
68
Cannula
 65
Material Integrity Problem
 63
Intermittent Continuity
58
Cord
 57
Packaging Problem
 55
Loss Of Or Failure To Bond
 54
Connection Problem
 54
Improper Or Incorrect Procedure Or Method
 51
Generator
 50
Difficult To Remove
49
Device Operational Issue
 48
Ring
 48
Failure To Shut Off
 46
Protective Measures Problem
 45
Image Display Error / Artifact
 45
Failure To Fire
43
Fracture
 41
Circuit Failure
 41
Catheter
 41
Environmental Particulates
 41
Crack
 39
Improper Flow Or Infusion
 37
Therapeutic Or Diagnostic Output Failure
 37
Pitted
 37
Device Inoperable
 37
Intermittent Loss Of Power
 36
Electromagnetic Interference
 36
Device Contamination With Chemical Or Other Material
 35
Flaked
 35
Failure To Adhere Or Bond
 34
Computer Operating System Problem
 33
Component Falling
 32
Defective Alarm
 31
Defective Device
 31
Device Packaging Compromised
 30
Handpiece
 30
Appropriate Term/Code Not Available
 30
Device Dislodged Or Dislocated
 30
Fluid Leak
 28
Noise, Audible
 28
Loose Or Intermittent Connection
 27
Hole In Material
 27
Failure To Obtain Sample
26
Missing Value Reason
 25
Charred
 25
Intermittent Energy Output
24
Unknown (for Use When The Device Problem Is Not Known)
 24
Total Device Problems 21895
Recalls
Manufacturer Recall Class Date Posted
1
3M Company - Health Care Business
 II Dec-03-2016
2
Aesculap Implant Systems LLC
 II Feb-16-2017
3
Alcon Research, Ltd.
 II Dec-12-2014
4
Angiodynamics
 II Feb-24-2015
5
Applied Medical Resources Corp
 II Sep-15-2015
6
ArthroCare Corporation
 II Apr-05-2016
7
ArthroCare Corporation
 II Jan-08-2016
8
ArthroCare Corporation
 II Jul-18-2015
9
ArthroCare Medical Corporation
 II Jun-25-2015
10
ArthroCare Medical Corporation
 II Mar-26-2015
11
ArthroCare Medical Corporation
 II Dec-16-2014
12
Beaver-Visitec International Inc.
 II May-10-2018
13
Beaver-Visitec International Inc.
 II Apr-27-2018
14
Bovie Medical Corporation
 II Oct-19-2018
15
Bovie Medical Corporation
 II Mar-21-2018
16
Bovie Medical Corporation
 II Aug-25-2016
17
COVIDIEN MEDTRONIC
 II Apr-18-2017
18
ConMed Corporation
 II Apr-07-2017
19
ConMed Corporation
 II Dec-01-2015
20
ConMed Corporation
 II Nov-03-2015
21
ConMed Corporation
 II Jun-20-2014
22
ConMed Corporation
 II Jun-04-2014
23
Conmed Corporation
 II Aug-19-2016
24
Covidien, PLC
 II Mar-18-2019
25
Dannoritzer Medizintechnik GmbH & Co. KG
 III Oct-03-2018
26
DePuy Mitek, Inc., A Johnson & Johnson Co.
 II Dec-23-2015
27
DeRoyal Industries Inc
 II May-01-2018
28
Domain Surgical, Inc.
 II Dec-01-2016
29
EXP Pharmaceutical Services Corp
 II Jul-24-2015
30
Ellman International, Inc.
 II Dec-13-2016
31
Gyrus Acmi, Incorporated
 II Jun-11-2015
32
Gyrus Medical, Inc
 II Oct-21-2014
33
Instrumed International, Inc.
 II Sep-30-2014
34
Integra LifeSciences Corp.
 II May-31-2016
35
Invuity, Inc.
 II Jul-28-2017
36
Maquet Cardiovascular, LLC
 II Mar-14-2017
37
Mederi Therapeutics, Inc
 II May-08-2017
38
Medtronic
 II Aug-17-2016
39
Medtronic Advanced Energy, LLC
 II Jan-31-2014
40
Megadyne Medical Products, Inc.
 II Aug-13-2018
41
Megadyne Medical Products, Inc.
 II Mar-07-2014
42
Microline Surgical
 II May-20-2014
43
Microline Surgical, Inc.
 II May-08-2018
44
Microline Surgical, Inc.
 II Feb-02-2018
45
Microline Surgical, Inc.
 II Jul-02-2014
46
Olsen Medical
 II May-25-2018
47
Stryker Endoscopy
 II Jun-24-2015
48
Stryker Endoscopy
 II May-02-2014
49
Teleflex Medical
 II Jan-18-2019
50
Teleflex Medical
 II Oct-31-2017
51
Teleflex Medical
 II Sep-27-2017
52
Teleflex Medical
 II Jan-15-2014
53
Terumo Cardiovascular Systems Corporation
 II Oct-24-2018
54
The Anspach Effort, Inc.
 II Jun-25-2014
TPLC Last Update: 2019-04-02 21:10:11
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