Clearance Summary
INDWELLING FECAL MANAGEMENT SYSTEM received FDA 510(k) clearance under submission number K012113, sponsored by Bowel Management Systems, LLC. 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 2002-05-03.
- Submission: K012113
- Applicant / Sponsor: Bowel Management Systems, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2002-05-03
Classification & Regulation
This clearance is catalogued under FDA product code KNT and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.