Clearance Summary
AUXILIARY INSTRUMENTS FOR URS received FDA 510(k) clearance under submission number K971315, 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 1997-09-15.
- Submission: K971315
- Applicant / Sponsor: Richard Wolf Medical Instruments Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1075
- Decision date: 1997-09-15
Classification & Regulation
This clearance is catalogued under FDA product code FCL and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class I device.