Clearance Summary
WORKING CHANNEL VALVE received FDA 510(k) clearance under submission number K900781, sponsored by Applied Urology, 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 1990-04-25.
- Submission: K900781
- Applicant / Sponsor: Applied Urology, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1500
- Decision date: 1990-04-25
Classification & Regulation
This clearance is catalogued under FDA product code FFY and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class I device.