Sterile Safety Hypodermic Needles for Single Use— 510(k) K221080

Substantially Equivalent

Sichuan Prius Biotechnology Co., Ltd.

FDA 510(k) clearance K221080 for Sterile Safety Hypodermic Needles for Single Use, Substantially Equivalent on 2022-10-04. Applicant: Sichuan Prius Biotechnology Co., Ltd..

Clearance details

Applicant: Sichuan Prius Biotechnology Co., Ltd.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2022-04-12
Decision date: 2022-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yibin, 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.