Sterile Syringe for Single Use— 510(k) K210914

Substantially Equivalent

Jiangsu Suyun Medical Material Co., Ltd.

FDA 510(k) clearance K210914 for Sterile Syringe for Single Use, Substantially Equivalent on 2021-12-17. Applicant: Jiangsu Suyun Medical Material Co., Ltd..

Clearance details

Applicant: Jiangsu Suyun Medical Material Co., Ltd.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2021-03-29
Decision date: 2021-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lianyungang, 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.