OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM
Device Facts
| Record ID | K943305 |
|---|---|
| Device Name | OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM |
| Applicant | Olympus America, Inc. |
| Product Code | HET · Obstetrics/Gynecology |
| Decision Date | Nov 17, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| 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.
