Sterile Hypodermic Needles for Single Use— 510(k) K210232

Substantially Equivalent

Zhejiang Kangkang Medical-Devices Co., Ltd.

FDA 510(k) clearance K210232 for Sterile Hypodermic Needles for Single Use, Substantially Equivalent on 2021-09-23. Applicant: Zhejiang Kangkang Medical-Devices Co., Ltd..

Clearance details

Applicant: Zhejiang Kangkang Medical-Devices Co., Ltd.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2021-01-28
Decision date: 2021-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yuhuan, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.