K240276
- 510(k) number
- K240276
- Device name
- PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software
- Applicant
- Given Imaging Ltd. (D.B.A. Medtronic) IL
- Product code
- NEZ — System, Imaging, Gastrointestinal, Wireless, Capsule
- Decision date
- 2024-05-10
- Date received
- 2024-01-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K240276.pdf
Official FDA record: K240276
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.