510(k) K143404— SurgiQuest AirSeal iFS System

Substantially Equivalent

Surgiquest, Inc.

Clearance details

Applicant: Surgiquest, Inc.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2014-11-28
Decision date: 2015-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milford, CT, US

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.