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 Type ID | 2026 |
Device Name | Electrode, Electrosurgical, Active, Urological, Reprocessed |
Regulation Description | Endoscopic Electrosurgical Unit And Accessories. |
Regulation Medical Specialty | Gastroenterology/Urology |
Review Panel | Gastroenterology/Urology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
Submission Type | 510(k) |
CFR Regulation Number | 876.4300 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | NLW |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2026 |
Device | Electrode, Electrosurgical, Active, Urological, Reprocessed |
Product Code | NLW |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Endoscopic Electrosurgical Unit And Accessories. |
CFR Regulation Number | 876.4300 [🔎] |