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

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..

Clearance details

Applicant: Shanghai Kohope Medical Devices Co., Ltd.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2019-01-02
Decision date: 2019-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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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.