Clearance Summary
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E received FDA 510(k) clearance under submission number K230991, sponsored by Given Imaging Ltd. (Medtronic). 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 2023-06-30.
- Submission: K230991
- Applicant / Sponsor: Given Imaging Ltd. (Medtronic)
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1300
- Decision date: 2023-06-30
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.