Clearance Summary
LM-9300 Plus Lithotripter received FDA 510(k) clearance under submission number K213772, sponsored by Lite-Med, Inc.. 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 2023-01-19.
- Submission: K213772
- Applicant / Sponsor: Lite-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5990
- Decision date: 2023-01-19
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.