O. B. PACK IV
Device Facts
| Record ID | K902032 |
|---|---|
| Device Name | O. B. PACK IV |
| Applicant | Customed, Inc. |
| Product Code | HFC · Obstetrics/Gynecology |
| Decision Date | Sep 28, 1990 |
| 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.
