DeviceClearance

K040893

Substantially Equivalent

EASY CORE BIOPSY SYSTEM

Applicant
Boston Scientific Corp
Product code
FCG
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Natick,, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FCG

product code FCG
Death
13
Injury
576
Malfunction
1,966
Total
2,555

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.