DeviceClearance

K160654

Substantially Equivalent

GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)

Applicant
Covidien, LLC
Product code
KNT
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
North Haven, CT, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KNT

product code KNT
Death
192
Injury
6,034
Malfunction
4,049
Other
1
Total
10,276

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 →

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