KARL STORZ HYSTEROMAT II
Device Facts
| Record ID | K000806 |
|---|---|
| Device Name | KARL STORZ HYSTEROMAT II |
| Applicant | KARL STORZ Endoscopy-America, Inc. |
| Product Code | HIG · Obstetrics/Gynecology |
| Decision Date | Nov 30, 2000 |
| 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.
