Clearance Summary
LINA XCISE MODEL MOR-1515 received FDA 510(k) clearance under submission number K101458, sponsored by Lina Medical Aps. 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 2011-03-11.
- Submission: K101458
- Applicant / Sponsor: Lina Medical Aps
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 2011-03-11
Classification & Regulation
This clearance is catalogued under FDA product code HET and 21 CFR 884.1720, within the Obstetrics/Gynecology review panel as a Class II device.