Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe— 510(k) K190183

Substantially Equivalent

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

FDA 510(k) clearance K190183 for Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe, Substantially Equivalent on 2019-10-04. Applicant: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd..

Clearance details

Applicant
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Product code
Code MEG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Taihu, Anqing City, 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.