Clearance Summary
LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS received FDA 510(k) clearance under submission number K033335, sponsored by Siemens Medical Solutions USA, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2003-11-25.
- Submission: K033335
- Applicant / Sponsor: Siemens Medical Solutions USA, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4890
- Decision date: 2003-11-25
Classification & Regulation
This clearance is catalogued under FDA product code MMZ and 21 CFR 876.4890, within the Gastroenterology, Urology review panel as a Class II device.