DC PACK TM
Device Facts
| Record ID | K821134 |
|---|---|
| Device Name | DC PACK TM |
| Applicant | Seamless Hospital Products Co. |
| Product Code | HFC · Obstetrics/Gynecology |
| Decision Date | Jun 22, 1982 |
| 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.
