Clearance Summary
INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO) received FDA 510(k) clearance under submission number K011065, sponsored by Richard Wolf Medical Instruments Corp.. 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 2001-05-09.
- Submission: K011065
- Applicant / Sponsor: Richard Wolf Medical Instruments Corp.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4480
- Decision date: 2001-05-09
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.