DeviceClearance

K173355

Unknown

Gastric Sizing Balloon Catheter

Applicant
Cook Incorporated
Product code
KNT
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Unknown
Clearance type
Special
Location
Bloomington, IN, 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.