Clearance Summary
MODIFIED BIO-FLOW MODEL 200 URINE FLOW DEVICE received FDA 510(k) clearance under submission number K862251, sponsored by Bio-Flow, 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 1986-09-04.
- Submission: K862251
- Applicant / Sponsor: Bio-Flow, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5250
- Decision date: 1986-09-04
Classification & Regulation
This clearance is catalogued under FDA product code KNX and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class II device.