Sterile Hypodermic Syringes for Single Use with Needles— 510(k) K221068

Substantially Equivalent

Sichuan Prius Biotechnology Co., Ltd.

FDA 510(k) clearance K221068 for Sterile Hypodermic Syringes for Single Use with Needles, Substantially Equivalent on 2022-10-04. Applicant: Sichuan Prius Biotechnology Co., Ltd..

Clearance details

Applicant: Sichuan Prius Biotechnology Co., Ltd.
Product code: Code FMF
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 FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.