Clearance Summary
URETHROTOME 8667.XXX AND 8670.XXX received FDA 510(k) clearance under submission number K000905, sponsored by Richard Wolf Medical Instruments Corp.. 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 2000-05-12.
- Submission: K000905
- Applicant / Sponsor: Richard Wolf Medical Instruments Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4770
- Decision date: 2000-05-12
Classification & Regulation
This clearance is catalogued under FDA product code EZO and 21 CFR 876.4770, within the Gastroenterology, Urology review panel as a Class II device.