Clearance Summary
SONOLITH I-SYS LITHOTRIPER received FDA 510(k) clearance under submission number K083614, sponsored by Technomed Medical Systems, SA. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2009-07-27.
- Submission: K083614
- Applicant / Sponsor: Technomed Medical Systems, SA
- Clearance pathway: Abbreviated
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5990
- Decision date: 2009-07-27
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.