NLU · Forceps, Biopsy, Electric, Reprocessed
Gastroenterology, Urology · 21 CFR 876.4300 · Class 2
Overview
| Product Code | NLU |
|---|---|
| Device Name | Forceps, Biopsy, Electric, Reprocessed |
| 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).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K050136 | REPROCESSED HOT BIOPSY FORCEPS | Sterilmed, Inc. | Jul 20, 2005 | SESE |
| K033593 | REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS | Clearmedical, Inc. | Nov 20, 2003 | SESE |
| K024011 | SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES | Surgical Instruments Service and Savings, Inc. | Dec 19, 2002 | SESE |
| K011800 | VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS | Vanguard Medical Concepts, Inc. | Sep 27, 2001 | SESE |
Top Applicants
- Vanguard Medical Concepts, Inc. — 1 clearance
- Surgical Instruments Service and Savings, Inc. — 1 clearance
- Sterilmed, Inc. — 1 clearance
- Clearmedical, Inc. — 1 clearance
