21 CFR 876.4300 — Unit, Electrosurgical
Gastroenterology, Urology (GU) · Subpart E—Surgical Devices · § 876.4300
Identification
An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FAR | Unit, Electrosurgical | 2 | 0 | |
| FAS | Electrode, Electrosurgical, Active, Urological | 2 | 58 | 3rd Party |
| FBJ | Cord, Electric For Transurethral Surgical Instrument | 2 | 0 | |
| FDB | Plate, Patient | 2 | 0 | |
| FDI | Snare, Flexible | 2 | 63 | 3rd Party |
| FDJ | Snare, Rigid Self-Opening | 2 | 0 | |
| FDL | Wristlet, Patient Return | 2 | 0 | |
| FEH | Electrode, Flexible Suction Coagulator | 2 | 3 | 3rd Party |
| FFI | System, Alarm, Electrosurgical | 2 | 1 | 3rd Party |
| FGW | Clamp, Electrical | 2 | 0 | |
| FHC | Adaptor To The Cord, For Transurethral Surgical Instrument | 2 | 0 | |
| FHY | Jelly, Contact, For Transurethral Surgical Instrument | 2 | 0 | 3rd Party |
| FHZ | Desiccator, Transurethral | 2 | 0 | |
| KGE | Forceps, Biopsy, Electric | 2 | 46 | 3rd Party |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 2 | 187 | 3rd Party |
| NLR | Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed | 2 | 1 | |
| NLT | Snare, Flexible, Reprocessed | 2 | 0 | |
| NLU | Forceps, Biopsy, Electric, Reprocessed | 2 | 4 | |
| NLV | Electrode, Flexible Suction Coagulator, Reprocessed | 2 | 0 | |
| NLW | Electrode, Electrosurgical, Active, Urological, Reprocessed | 2 | 1 | |
| NWI | Electrosurgical Electrode Kit | 2 | 0 | |
| OEJ | Transurethral Electrosurgical Unit, Benign Prostatic Hyperplasia | 2 | 0 | |
| OEK | Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia | 2 | 0 | |
| QEC | Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree | 2 | 1 |
