OBSTETRIC CUP (MODIFICATION)— 510(k) K891465

Substantially Equivalent

Go Medical Industries Pty. , Ltd.

FDA 510(k) clearance K891465 for OBSTETRIC CUP (MODIFICATION), Substantially Equivalent on 1989-05-11. Applicant: Go Medical Industries Pty. , Ltd..

Clearance details

Applicant: Go Medical Industries Pty. , Ltd.
Product code: Code HDB
Advisory panel: Obstetrics/Gynecology
Date received: 1989-03-15
Decision date: 1989-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Subiaco, Perth, AU

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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.