DeviceClearance

SurgiQuest AirSeal iFS System— 510(k) K143404

Substantially Equivalent

Surgiquest, Inc.

FDA 510(k) clearance K143404 for SurgiQuest AirSeal iFS System, Substantially Equivalent on 2015-03-20. Applicant: Surgiquest, Inc.. Device class: 2.

Clearance details

Applicant
Surgiquest, Inc.
Product code
Code HIF
Device class
Class 2
Regulation
21 CFR 884.1730
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Milford, CT, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code HIF

view all

More clearances from Surgiquest, Inc.

view all

Adverse events under product code HIF

product code HIF
Death
19
Injury
578
Malfunction
5,639
Total
6,236

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K143404

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143404.

Data sourced from openFDA. This site is unofficial and independent of the FDA.