Clearance Summary
ESTEEM INCONTINENT SYSTEM received FDA 510(k) clearance under submission number K852276, sponsored by Bevan Medical, 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 1985-08-07.
- Submission: K852276
- Applicant / Sponsor: Bevan Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5920
- Decision date: 1985-08-07
Classification & Regulation
This clearance is catalogued under FDA product code EYQ and 21 CFR 876.5920, within the Gastroenterology, Urology review panel as a Class I device.