AdvanCE capsule endoscope delivery device— 510(k) K163495

Substantially Equivalent

United States Endoscopy Group, Inc.

FDA 510(k) clearance K163495 for AdvanCE capsule endoscope delivery device, Substantially Equivalent on 2017-03-10. Applicant: United States Endoscopy Group, Inc..

Clearance details

Applicant: United States Endoscopy Group, Inc.
Product code: Code NEZ
Advisory panel: Gastroenterology, Urology
Date received: 2016-12-13
Decision date: 2017-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

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.