DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM)
Device Facts
| Record ID | K910254 |
|---|---|
| Device Name | DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) |
| Applicant | CooperSurgical, Inc. |
| Product Code | HHE · Obstetrics/Gynecology |
| Decision Date | Apr 18, 1991 |
| Decision | SESD |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
Special Controls
*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.
