CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144— 510(k) K040494

Substantially Equivalent

United States Endoscopy Group, Inc.

FDA 510(k) clearance K040494 for CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144, Substantially Equivalent on 2004-06-23. Applicant: United States Endoscopy Group, Inc..

Clearance details

Applicant: United States Endoscopy Group, Inc.
Product code: Code NEZ
Advisory panel: Gastroenterology, Urology
Date received: 2004-02-26
Decision date: 2004-06-23
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.