Clearance Summary
UROVIEW received FDA 510(k) clearance under submission number K872022, sponsored by Oec-Diasonics, Inc.. 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 1987-07-16.
- Submission: K872022
- Applicant / Sponsor: Oec-Diasonics, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4890
- Decision date: 1987-07-16
Classification & Regulation
This clearance is catalogued under FDA product code KQS and 21 CFR 876.4890, within the Gastroenterology, Urology review panel as a Class I device.