Electrode, Gel, Electrosurgical

Device Code: 5694

Product Code(s): JOT

Device Classification Information

Device Type ID5694
Device NameElectrode, Gel, Electrosurgical
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)
Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1)
Submission Type510(k)
CFR Regulation Number878.4400 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeJOT
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID5694
DeviceElectrode, Gel, Electrosurgical
Product CodeJOT
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionElectrosurgical Cutting And Coagulation Device And Accessories.
CFR Regulation Number878.4400 [🔎]
TPLC Last Update: 2019-04-02 21:10:56

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