Clearance Summary
Mendit received FDA 510(k) clearance under submission number K260380, sponsored by Escala Medical, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2026-03-04.
- Submission: K260380
- Applicant / Sponsor: Escala Medical, Ltd.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2026-03-04
Classification & Regulation
This clearance is catalogued under FDA product code PBQ and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.