Clearance Summary
GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO received FDA 510(k) clearance under submission number K042960, 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 2004-11-24.
- Submission: K042960
- Applicant / Sponsor: Given Imaging , Ltd.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1300
- Decision date: 2004-11-24
Classification & Regulation
This clearance is catalogued under FDA product code NSI and 21 CFR 876.1300, within the Gastroenterology, Urology review panel as a Class II device.