510(k) K232677
K232677 is an FDA 510(k) premarket notification submitted by Reia, LLC for the device "Reia pessary". The FDA issued a decision of Substantially Equivalent on May 21, 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
- May 21, 2024
- Date Received
- September 1, 2023
- 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