Clearance Summary
LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 received FDA 510(k) clearance under submission number K070315, 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 2007-10-30.
- Submission: K070315
- Applicant / Sponsor: Lina Medical Aps
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4160
- Decision date: 2007-10-30
Classification & Regulation
This clearance is catalogued under FDA product code KNF and 21 CFR 884.4160, within the Obstetrics/Gynecology review panel as a Class II device.