Clearance Summary
SAFESEAL REUSABLE URINAL SYSTEM received FDA 510(k) clearance under submission number K851682, sponsored by Dbt Medical , Ltd.. 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 1985-06-24.
- Submission: K851682
- Applicant / Sponsor: Dbt Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5250
- Decision date: 1985-06-24
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.