APA Oxy Blade— 510(k) K191602

Substantially Equivalent

Venner Medical (Singapore) Pte, Ltd.

FDA 510(k) clearance K191602 for APA Oxy Blade, Substantially Equivalent on 2019-08-02. Applicant: Venner Medical (Singapore) Pte, Ltd..

Clearance details

Applicant: Venner Medical (Singapore) Pte, Ltd.
Product code: Code CCW
Advisory panel: Anesthesiology
Date received: 2019-06-17
Decision date: 2019-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

Adverse events under product code CCW

product code CCW

Death: 31
Injury: 136
Malfunction: 3,703
Other: 1
Total: 3,871

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.