Clearance Summary
AbClose - Port Site Closure Device received FDA 510(k) clearance under submission number K160117, sponsored by Medeon Biodesign, 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 2016-09-09.
- Submission: K160117
- Applicant / Sponsor: Medeon Biodesign, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2016-09-09
Classification & Regulation
This clearance is catalogued under FDA product code OCW and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.