Clearance Summary
Speedicath Compact Male received FDA 510(k) clearance under submission number K143182, 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 2015-01-20.
- Submission: K143182
- Applicant / Sponsor: Coloplast A/S
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2015-01-20
Classification & Regulation
This clearance is catalogued under FDA product code GBM and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.