Clearance Summary
Perifit Care+ received FDA 510(k) clearance under submission number K231780, sponsored by X6 Innovations. 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 2023-12-20.
- Submission: K231780
- Applicant / Sponsor: X6 Innovations
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1425
- Decision date: 2023-12-20
Classification & Regulation
This clearance is catalogued under FDA product code HIR and 21 CFR 884.1425, within the Obstetrics/Gynecology review panel as a Class II device.