Clearance Summary
LITHOTRIPTOR SYSTEM MODEL 27080 received FDA 510(k) clearance under submission number K905553, sponsored by Karl Storz GmbH & Co. (Kst). 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 1991-06-04.
- Submission: K905553
- Applicant / Sponsor: Karl Storz GmbH & Co. (Kst)
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4480
- Decision date: 1991-06-04
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.