PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software— 510(k) K240276
Substantially EquivalentGiven Imaging Ltd. (D.B.A. Medtronic)
FDA 510(k) clearance K240276 for PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software, Substantially Equivalent on 2024-05-10. Applicant: Given Imaging Ltd. (D.B.A. Medtronic).
Clearance details
- Applicant
- Given Imaging Ltd. (D.B.A. Medtronic)
- Product code
- Code NEZ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yoqneam Northern, IL
Adverse events under product code NEZ
product code NEZ- Death
- 11
- Injury
- 218
- Total
- 229
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.