21 CFR 884.1175 — Curette, Suction, Endometrial (And Accessories)
Obstetrics/Gynecology (OB) · Part 884 Subpart B—Obstetrical and Gynecological Diagnostic Devices · § 884.1175
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HHK | Curette, Suction, Endometrial (And Accessories) | 2 | 42 | 3rd Party |
| OKZ | Endometrial Sampling Kit | 2 | 0 |