Sterile hypodermic syringes for single use— 510(k) K211728

Name: FDA 510(k) clearance K211728
Creator: U.S. Food and Drug Administration
Published: 2021-10-05

Substantially Equivalent

Jiangsu Kangyou Medical Instrument Co., Ltd.

FDA 510(k) clearance K211728 for Sterile hypodermic syringes for single use, Substantially Equivalent on 2021-10-05. Applicant: Jiangsu Kangyou Medical Instrument Co., Ltd.. Device class: 2.

Clearance details

Applicant: Jiangsu Kangyou Medical Instrument Co., Ltd.
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2021-06-04
Decision date: 2021-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jintan, CN

Download summary PDF View on FDA.gov ↗

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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.