Definition: This Device Is Intended To Be Used Endoscopically To Remove Tissue And Control Bleeding By Use Of High Frequency Electrical Current. This Device Is Indicated For Reuse/reprocessing.
| Device Type ID | 2021 |
| Device Name | Unit, Electrosurgical, Endoscopic (with Or Without Accessories), 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 | NLR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2021 |
| Device | Unit, Electrosurgical, Endoscopic (with Or Without Accessories), Reprocessed |
| Product Code | NLR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscopic Electrosurgical Unit And Accessories. |
| CFR Regulation Number | 876.4300 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Or Device Component | 2 |
Entrapment Of Device | 1 |
| Total Device Problems | 3 |