Safety Auto-Disable Syrine with Needle (Auto-Lock)— 510(k) K143497

Substantially Equivalent

Guangdong Intmed Medical Appliance Co., Ltd.

FDA 510(k) clearance K143497 for Safety Auto-Disable Syrine with Needle (Auto-Lock), Substantially Equivalent on 2015-11-04. Applicant: Guangdong Intmed Medical Appliance Co., Ltd..

Clearance details

Applicant
Guangdong Intmed Medical Appliance Co., Ltd.
Product code
Code MEG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Foshan, 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.