510(k) K233548
K233548 is an FDA 510(k) premarket notification submitted by Resilia, Inc. for the device "Uresta®". The FDA issued a decision of Substantially Equivalent on April 3, 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
- April 3, 2024
- Date Received
- November 3, 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