Clearance Summary
GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM received FDA 510(k) clearance under submission number K123864, sponsored by Given Imaging , Ltd.. 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 2013-08-12.
- Submission: K123864
- Applicant / Sponsor: Given Imaging , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1300
- Decision date: 2013-08-12
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.