HYSTEROFLATOR 1500
Device Facts
| Record ID | K911844 |
|---|---|
| Device Name | HYSTEROFLATOR 1500 |
| Applicant | F.M. Wiest USA, Inc. |
| Product Code | HIG · Obstetrics/Gynecology |
| Decision Date | Nov 21, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.1700 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.
