DeviceClearance

K172575

Substantially Equivalent

BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap

Applicant
Baronova, Inc.
Product code
FED
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Carlos, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FED

product code FED
Death
10
Total
10

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.