Clearance Summary
CONVEEN URINE BAG - STERILE received FDA 510(k) clearance under submission number K955609, sponsored by Coloplast Corp.. 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 1995-12-29.
- Submission: K955609
- Applicant / Sponsor: Coloplast Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5250
- Decision date: 1995-12-29
Classification & Regulation
This clearance is catalogued under FDA product code FAQ and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class I device.