Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use— 510(k) K190002

Name: FDA 510(k) clearance K190002
Creator: U.S. Food and Drug Administration
Published: 2019-09-12

Substantially Equivalent

Shanghai Kohope Medical Devices Co., Ltd.

FDA 510(k) clearance K190002 for Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use, Substantially Equivalent on 2019-09-12. Applicant: Shanghai Kohope Medical Devices Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Kohope Medical Devices Co., Ltd.
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2019-01-02
Decision date: 2019-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, 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.