ACCU-PAP T ZONE SAMPLER
Device Facts
| Record ID | K801238 |
|---|---|
| Device Name | ACCU-PAP T ZONE SAMPLER |
| Applicant | Robert Hasselbrack, M.D. |
| Product Code | HFC · Obstetrics/Gynecology |
| Decision Date | Aug 12, 1980 |
| 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.
