DeviceClearance

K894259

Substantially Equivalent

REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA

Applicant
Washington Regulatory Services
Product code
HIG
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ringoes, NJ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code HIG

product code HIG
Death
8
Other
2
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.