Clearance Summary
DIAMOND-FLEX(R) GRASPERS received FDA 510(k) clearance under submission number K110257, sponsored by Carefusion 2200, 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 2011-05-06.
- Submission: K110257
- Applicant / Sponsor: Carefusion 2200, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2011-05-06
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.