KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP
Device Facts
| Record ID | K950961 |
|---|---|
| Device Name | KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP |
| Applicant | KARL STORZ Endoscopy-America, Inc. |
| Product Code | HIG · Obstetrics/Gynecology |
| Decision Date | May 25, 1995 |
| 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.
