DeviceClearance

K090217

Substantially Equivalent

BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070

Applicant
Coloplast A/S
Product code
FBK
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Plymouth, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FBK

product code FBK
Other
1
Total
1

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.