Clearance Summary
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH received FDA 510(k) clearance under submission number K924407, 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 1992-09-23.
- Submission: K924407
- Applicant / Sponsor: Coloplast A/S
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5250
- Decision date: 1992-09-23
Classification & Regulation
This clearance is catalogued under FDA product code EXJ and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class I device.