Clearance Summary
CONVEEN INTERMITTENT CATHETERS received FDA 510(k) clearance under submission number K895548, sponsored by Coloplast A/S. 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 1990-02-09.
- Submission: K895548
- Applicant / Sponsor: Coloplast A/S
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1990-02-09
Classification & Regulation
This clearance is catalogued under FDA product code KOD and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.