GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES— 510(k) K101250

Substantially Equivalent

Given Imaging , Ltd.

FDA 510(k) clearance K101250 for GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES, Substantially Equivalent on 2011-03-07. Applicant: Given Imaging , Ltd..

Clearance details

Applicant: Given Imaging , Ltd.
Product code: Code NEZ
Advisory panel: Gastroenterology, Urology
Date received: 2010-05-04
Decision date: 2011-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yoqneaam, 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.