Optimus NEURO System - Sterile Kit— 510(k) K190811

Substantially Equivalent

Osteonic Co., Ltd.

FDA 510(k) clearance K190811 for Optimus NEURO System - Sterile Kit, Substantially Equivalent on 2019-11-27. Applicant: Osteonic Co., Ltd..

Clearance details

Applicant: Osteonic Co., Ltd.
Product code: Code GWO
Advisory panel: Neurology
Date received: 2019-03-29
Decision date: 2019-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWO

product code GWO

Malfunction: 583
Total: 583

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.