Clearance Summary
Bowel Management Device, Bowel Management Irrigation Set received FDA 510(k) clearance under submission number K180026, sponsored by Applied Medical Technology, 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 2018-06-01.
- Submission: K180026
- Applicant / Sponsor: Applied Medical Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2018-06-01
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.