PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0— 510(k) K170210

Substantially Equivalent

Given Imaging , Ltd.

FDA 510(k) clearance K170210 for PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0, Substantially Equivalent on 2017-09-01. Applicant: Given Imaging , Ltd..

Clearance details

Applicant: Given Imaging , Ltd.
Product code: Code NEZ
Advisory panel: Gastroenterology, Urology
Date received: 2017-01-24
Decision date: 2017-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yoqneam, 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.