PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA— 510(k) K132203

Substantially Equivalent

Lexion Medical, LLC

FDA 510(k) clearance K132203 for PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA, Substantially Equivalent on 2013-09-20. Applicant: Lexion Medical, LLC.

Clearance details

Applicant: Lexion Medical, LLC
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2013-07-16
Decision date: 2013-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.