KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE
Device Facts
| Record ID | K935716 |
|---|---|
| Device Name | KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE |
| Applicant | KARL STORZ Endoscopy-America, Inc. |
| Product Code | HIH · Obstetrics/Gynecology |
| Decision Date | Nov 16, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.1690 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.
