510(k) K910254
K910254 is an FDA 510(k) premarket notification submitted by CooperSurgical, Inc. for the device "DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM)". The FDA issued a decision of Substantially Equivalent (with conditions) on April 18, 1991. The device falls under product code HHE (Cup, Menstrual), a Class II device regulated under 21 CFR 884.5400. CooperSurgical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESD (Substantially Equivalent (with conditions))
- Decision Date
- April 18, 1991
- Date Received
- January 22, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cup, Menstrual
- Device Class
- Class II
- Regulation Number
- 884.5400
- Review Panel
- OB
- Submission Type
A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.