AQUASHIELD CO2 SYSTEM— 510(k) K120123

Substantially Equivalent

United States Endoscopy Group, Inc.

FDA 510(k) clearance K120123 for AQUASHIELD CO2 SYSTEM, Substantially Equivalent on 2012-03-28. Applicant: United States Endoscopy Group, Inc..

Clearance details

Applicant: United States Endoscopy Group, Inc.
Product code: Code FEQ
Advisory panel: Gastroenterology, Urology
Date received: 2012-01-17
Decision date: 2012-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FEQ

product code FEQ

Malfunction: 1,135
Total: 1,135

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.