Disposable High Pressure Syringe— 510(k) K170279

Substantially Equivalent

Union Medical Shenzhen Co., Ltd.

FDA 510(k) clearance K170279 for Disposable High Pressure Syringe, Substantially Equivalent on 2017-12-12. Applicant: Union Medical Shenzhen Co., Ltd..

Clearance details

Applicant: Union Medical Shenzhen Co., Ltd.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2017-01-30
Decision date: 2017-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.