21 CFR 884.5400 — Cup, Menstrual
Obstetrics/Gynecology (OB) · Part 884 Subpart F—Obstetrical and Gynecological Therapeutic Devices · § 884.5400
Identification
A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HHE | Cup, Menstrual | 2 | 16 |
Special Controls
HHE — Cup, Menstrual
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
eCFR
