510(k) K240798
K240798 is an FDA 510(k) premarket notification submitted by Cntrl+, Inc. for the device "Cntrl+ Bladder Support Pessary". The FDA issued a decision of Substantially Equivalent on December 17, 2024. The device falls under product code HHW (Pessary, Vaginal), a Class II device regulated under 21 CFR 884.3575.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2024
- Date Received
- March 22, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pessary, Vaginal
- Device Class
- Class II
- Regulation Number
- 884.3575
- Review Panel
- OB
- Submission Type