Clearance Summary
EndoCure Model EUR078A received FDA 510(k) clearance under submission number K161147, sponsored by Endocure Technologies, 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 2016-06-07.
- Submission: K161147
- Applicant / Sponsor: Endocure Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2016-06-07
Classification & Regulation
This clearance is catalogued under FDA product code FBN and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.