AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM— 510(k) K191559

Name: FDA 510(k) clearance K191559
Creator: U.S. Food and Drug Administration
Published: 2019-08-01

Substantially Equivalent

United States Endoscopy Group, Inc.

FDA 510(k) clearance K191559 for AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM, Substantially Equivalent on 2019-08-01. Applicant: United States Endoscopy Group, Inc.. Device class: 2.

Clearance details

Applicant: United States Endoscopy Group, Inc.
Product code: Code FEQ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2019-06-13
Decision date: 2019-08-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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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.