OKZ · Endometrial Sampling Kit
Obstetrics/Gynecology · 21 CFR 884.1175 · Class 2
Overview
| Product Code | OKZ |
|---|---|
| Device Name | Endometrial Sampling Kit |
| Regulation | 21 CFR 884.1175 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.