Clearance Summary
Koala Intrauterine Pressure Catheter (IPC-5000E) received FDA 510(k) clearance under submission number K250897, sponsored by Clinical Innovations, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2025-05-22.
- Submission: K250897
- Applicant / Sponsor: Clinical Innovations, LLC
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2700
- Decision date: 2025-05-22
Classification & Regulation
This clearance is catalogued under FDA product code HFN and 21 CFR 884.2700, within the Obstetrics/Gynecology review panel as a Class II device.