21 CFR 884.5250 — Cap, Cervical
Obstetrics/Gynecology (OB) · Part 884 Subpart F—Obstetrical and Gynecological Therapeutic Devices · § 884.5250
Identification
A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HDR | Cap, Cervical | 2 | 29 | 3rd Party |
| MFD | Cannula, Intrauterine Insemination | 2 | 29 | |
| OBB | Kit, Conception-Assist, Home Use | 2 | 4 |