Clearance Summary
LITHODIAMOND ULTRA received FDA 510(k) clearance under submission number K061350, sponsored by Pck Electronic Industry & Trade Co., Ltd.. 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 2006-12-22.
- Submission: K061350
- Applicant / Sponsor: Pck Electronic Industry & Trade Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5990
- Decision date: 2006-12-22
Classification & Regulation
This clearance is catalogued under FDA product code LNS and 21 CFR 876.5990, within the Gastroenterology, Urology review panel as a Class II device.