Clearance Summary
Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit received FDA 510(k) clearance under submission number K153506, sponsored by Consure Medical Pvt , 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 2016-05-06.
- Submission: K153506
- Applicant / Sponsor: Consure Medical Pvt , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2016-05-06
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.