Clearance Summary
PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software received FDA 510(k) clearance under submission number K240276, sponsored by Given Imaging Ltd. (D.B.A. Medtronic). 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 2024-05-10.
- Submission: K240276
- Applicant / Sponsor: Given Imaging Ltd. (D.B.A. Medtronic)
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1300
- Decision date: 2024-05-10
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.