Clearance Summary
Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) received FDA 510(k) clearance under submission number K243291, sponsored by Neoventa Medical AB. 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 2025-01-17.
- Submission: K243291
- Applicant / Sponsor: Neoventa Medical AB
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2675
- Decision date: 2025-01-17
Classification & Regulation
This clearance is catalogued under FDA product code HGP and 21 CFR 884.2675, within the Obstetrics/Gynecology review panel as a Class II device.