ANAL RECTAL OVERTUBE— 510(k) K131598

Substantially Equivalent

United States Endoscopy Group, Inc.

FDA 510(k) clearance K131598 for ANAL RECTAL OVERTUBE, Substantially Equivalent on 2014-02-26. Applicant: United States Endoscopy Group, Inc..

Clearance details

Applicant: United States Endoscopy Group, Inc.
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 2013-06-03
Decision date: 2014-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.