BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA— 510(k) K102328

Substantially Equivalent

Shandong Weigao Group Medical Polymer Co., Ltd.

FDA 510(k) clearance K102328 for BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA, Substantially Equivalent on 2011-05-13. Applicant: Shandong Weigao Group Medical Polymer Co., Ltd..

Clearance details

Applicant: Shandong Weigao Group Medical Polymer Co., Ltd.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2010-08-17
Decision date: 2011-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.