SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE— 510(k) K895594

Substantially Equivalent

Go Medical Industries Pty. , Ltd.

FDA 510(k) clearance K895594 for SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE, Substantially Equivalent on 1989-10-06. Applicant: Go Medical Industries Pty. , Ltd..

Clearance details

Applicant: Go Medical Industries Pty. , Ltd.
Product code: Code GDM
Advisory panel: General, Plastic Surgery
Date received: 1989-09-15
Decision date: 1989-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Subiaco, Perth, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code GDM

product code GDM

Death: 2
Total: 2

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.