510(k) K222969
K222969 is an FDA 510(k) premarket notification submitted by Rosesta Medical BV for the device "FERTI-LILY Conception Cup". The FDA issued a decision of Substantially Equivalent on June 23, 2023. The device falls under product code HDR (Cap, Cervical), a Class II device regulated under 21 CFR 884.5250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2023
- Date Received
- September 27, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cap, Cervical
- Device Class
- Class II
- Regulation Number
- 884.5250
- Review Panel
- OB
- Submission Type