APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
Device Facts
| Record ID | K000026 |
|---|---|
| Device Name | APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER |
| Applicant | Apple Medical Corp. |
| Product Code | HHK · Obstetrics/Gynecology |
| Decision Date | Mar 31, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.1175 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.