HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR
Device Facts
| Record ID | K905495 |
|---|---|
| Device Name | HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR |
| Applicant | Frigitronics, Inc. |
| Product Code | HIG · Obstetrics/Gynecology |
| Decision Date | Apr 29, 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.
