Clearance Summary
EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) received FDA 510(k) clearance under submission number K012445, sponsored by Electro Medical Systems SA. 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 2001-08-24.
- Submission: K012445
- Applicant / Sponsor: Electro Medical Systems SA
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4480
- Decision date: 2001-08-24
Classification & Regulation
This clearance is catalogued under FDA product code FFK and 21 CFR 876.4480, within the Gastroenterology, Urology review panel as a Class II device.