O'NEIL OBSTETRIC CUP— 510(k) K840008

Substantially Equivalent

Go Medical Industries Pty. , Ltd.

FDA 510(k) clearance K840008 for O'NEIL OBSTETRIC CUP, Substantially Equivalent on 1984-04-25. Applicant: Go Medical Industries Pty. , Ltd..

Clearance details

Applicant: Go Medical Industries Pty. , Ltd.
Product code: Code HDB
Advisory panel: Obstetrics/Gynecology
Date received: 1984-01-04
Decision date: 1984-04-25
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, 2020-01-01 through 2026-04-23. 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.