Disposable Syringe with Needle— 510(k) K211482

Substantially Equivalent

Shandong Qinkai Medical Industry Co., Ltd.

FDA 510(k) clearance K211482 for Disposable Syringe with Needle, Substantially Equivalent on 2022-01-24. Applicant: Shandong Qinkai Medical Industry Co., Ltd..

Clearance details

Applicant: Shandong Qinkai Medical Industry Co., Ltd.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2021-05-12
Decision date: 2022-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Heze City, 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.