MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET
Device Facts
| Record ID | K003417 |
|---|---|
| Device Name | MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET |
| Applicant | Richard Wolf Medical Instruments Corp. |
| Product Code | HET · Obstetrics/Gynecology |
| Decision Date | Apr 4, 2001 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 884.1720 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.
