Clearance Summary
PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT received FDA 510(k) clearance under submission number K091405, 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 2009-07-29.
- Submission: K091405
- Applicant / Sponsor: Given Imaging , Ltd.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1300
- Decision date: 2009-07-29
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.