Sterile Auto-Disable Syringes with/without Needle for Single Use— 510(k) K210229

Substantially Equivalent

Zhejiang Kangkang Medical-Devices Co., Ltd.

FDA 510(k) clearance K210229 for Sterile Auto-Disable Syringes with/without Needle for Single Use, Substantially Equivalent on 2022-02-15. Applicant: Zhejiang Kangkang Medical-Devices Co., Ltd..

Clearance details

Applicant
Zhejiang Kangkang Medical-Devices Co., Ltd.
Product code
Code MEG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Yuhuan, CN
Download summary PDFView on FDA.gov ↗

Adverse events under product code MEG

product code MEG
Malfunction
1,373
Other
1
Total
1,374

Source: openFDA MAUDE database, through . 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.