PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E— 510(k) K211684

Substantially Equivalent

Given Imaging Ltd. (Medtronic)

FDA 510(k) clearance K211684 for PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E, Substantially Equivalent on 2021-08-27. Applicant: Given Imaging Ltd. (Medtronic).

Clearance details

Applicant: Given Imaging Ltd. (Medtronic)
Product code: Code NEZ
Advisory panel: Gastroenterology, Urology
Date received: 2021-06-01
Decision date: 2021-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yoqneam Northern, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code NEZ

product code NEZ

Death: 11
Injury: 218
Total: 229

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.