Electrode, Electrosurgical, Active, Urological, Reprocessed

Device Code: 2026

Product Code(s): NLW

Definition: The "electrode, Electrosurgical, Active, Urological, Reprocessed" Is Intended To Be Used Endoscopically To Contact Urologic Tissue So As To Allow Cutting, Coagulation, Electrodesiccation, Or Cautery Dessication By Means Of Electric Current. This Devi

Device Classification Information

Device Type ID2026
Device NameElectrode, Electrosurgical, Active, Urological, 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 CodeNLW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2026
DeviceElectrode, Electrosurgical, Active, Urological, Reprocessed
Product CodeNLW
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEndoscopic Electrosurgical Unit And Accessories.
CFR Regulation Number876.4300 [🔎]
TPLC Last Update: 2019-04-02 20:04:37

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