Clearance Summary
MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM received FDA 510(k) clearance under submission number K070475, sponsored by Given Imaging , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2007-05-07.
- Submission: K070475
- Applicant / Sponsor: Given Imaging , Ltd.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1300
- Decision date: 2007-05-07
Classification & Regulation
This clearance is catalogued under FDA product code NEZ and 21 CFR 876.1300, within the Gastroenterology, Urology review panel as a Class II device.