QEC · Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree
Gastroenterology, Urology · 21 CFR 876.4300 · Class 2
Overview
| Product Code | QEC |
|---|---|
| Device Name | Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree |
| Regulation | 21 CFR 876.4300 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
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).
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K173495 | Single Use Hot Biopsy Forceps FD-231 | Olympus Medical Systems Corp. | Nov 30, 2018 | SESE |
Top Applicants
- Olympus Medical Systems Corp. — 1 clearance
