Electrode, Flexible Suction Coagulator, Reprocessed

Device Code: 2025

Product Code(s): NLV

Definition: The "electorde, Flexible Suction Coagulator, Reprocessed" Is Intended To Be Used Endoscopically To Provide Simultaneous Suction Of Fluids And Coagulation Of Tissue. This Device Is Indicated For Reuse/reprocessing.

Device Classification Information

Device Type ID2025
Device NameElectrode, Flexible Suction Coagulator, Reprocessed
Regulation DescriptionEndoscopic Electrosurgical Unit And Accessories.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Urology And Lithotripsy Devices Branch (ULDB)
Submission Type510(k)
CFR Regulation Number876.4300 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNLV
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2025
DeviceElectrode, Flexible Suction Coagulator, Reprocessed
Product CodeNLV
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEndoscopic Electrosurgical Unit And Accessories.
CFR Regulation Number876.4300 [🔎]
TPLC Last Update: 2019-04-02 20:04:36

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