Clearance Summary
COVER-ALL MALE INCONTINENCE DEVICE received FDA 510(k) clearance under submission number K801629, sponsored by The Urology Group. 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 1980-08-12.
- Submission: K801629
- Applicant / Sponsor: The Urology Group
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5250
- Decision date: 1980-08-12
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.