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 Type ID | 2025 |
Device Name | Electrode, Flexible Suction Coagulator, 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 | NLV |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2025 |
Device | Electrode, Flexible Suction Coagulator, Reprocessed |
Product Code | NLV |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Endoscopic Electrosurgical Unit And Accessories. |
CFR Regulation Number | 876.4300 [🔎] |