DISPO-URETTE
Device Facts
| Record ID | K860796 |
|---|---|
| Device Name | DISPO-URETTE |
| Applicant | Roland J. Zwick, Inc. |
| Product Code | PCF · Obstetrics/Gynecology |
| Decision Date | Apr 8, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.1050 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An endocervical aspirator is a device designed to remove tissue from the endocervix (mucous membrane lining the canal of the cervix of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to evaluate endocervical tissue to detect malignant and premalignant lesions.
