MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT
Device Facts
| Record ID | K962653 |
|---|---|
| Device Name | MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT |
| Applicant | Microgyn Corp. |
| Product Code | FAS · Gastroenterology, Urology |
| Decision Date | Feb 4, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.4300 |
| Device Class | Class 2 |
Regulatory Classification
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.
