Clearance Summary
LiNA OperaScope Needle received FDA 510(k) clearance under submission number K221085, sponsored by Lina Medical Aps. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2022-09-02.
- Submission: K221085
- Applicant / Sponsor: Lina Medical Aps
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2022-09-02
Classification & Regulation
This clearance is catalogued under FDA product code FBK and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.