Generator, Electrosurgical, Coagulation, Cancer

Device Code: 5751

Product Code(s): MUL

Device Classification Information

Device Type ID5751
Device NameGenerator, Electrosurgical, Coagulation, Cancer
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 One - Light Based/Laser (GSDB1)
Submission Type510(k)
CFR Regulation Number878.4400 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMUL
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 ID5751
DeviceGenerator, Electrosurgical, Coagulation, Cancer
Product CodeMUL
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionElectrosurgical Cutting And Coagulation Device And Accessories.
CFR Regulation Number878.4400 [🔎]
TPLC Last Update: 2019-04-02 21:11:55

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