DeviceClearance

K173559

Substantially Equivalent

Barrx SB RFA Endoscopic Catheter

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

Adverse events under product code KNS

product code KNS
Death
44
Injury
2,361
Malfunction
4,771
Total
7,176

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.