DeviceClearance

K840008

Substantially Equivalent

O'NEIL OBSTETRIC CUP

Applicant
Go Medical Industries Pty. , Ltd.
Product code
HDB
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code HDB

product code HDB
Death
7
Total
7

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.