FEH · Electrode, Flexible Suction Coagulator
Gastroenterology, Urology · 21 CFR 876.4300 · Class 2
Overview
| Product Code | FEH |
|---|---|
| Device Name | Electrode, Flexible Suction Coagulator |
| Regulation | 21 CFR 876.4300 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
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 (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K130489 | ELECTRODE, FLEXIBLE SUCTION COAGULATOR | Optim, LLC | Apr 19, 2013 | SESE |
| K122593 | PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 | Optim, LLC | Sep 13, 2012 | SESE |
| K803214 | ACMI BIPOLAR HEMOSTATIC ELECTRODE | American Cystocope Makers, Inc. | Jan 15, 1981 | SESE |
Top Applicants
- Optim, LLC — 2 clearances
- American Cystocope Makers, Inc. — 1 clearance
