Clearance Summary
SPEEDICATH COMPACT SET (12/18 FR) received FDA 510(k) clearance under submission number K121458, 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 2012-10-01.
- Submission: K121458
- Applicant / Sponsor: Coloplast A/S
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2012-10-01
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.