Clearance Summary
CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT received FDA 510(k) clearance under submission number K880034, sponsored by Lin-Mark, Inc.. 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 1988-03-02.
- Submission: K880034
- Applicant / Sponsor: Lin-Mark, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5250
- Decision date: 1988-03-02
Classification & Regulation
This clearance is catalogued under FDA product code KNX and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class II device.