3S Safety Syringe with/without Needle— 510(k) K142435

Substantially Equivalent

Sincere Medical Device Co., Ltd.

FDA 510(k) clearance K142435 for 3S Safety Syringe with/without Needle, Substantially Equivalent on 2015-02-20. Applicant: Sincere Medical Device Co., Ltd..

Clearance details

Applicant
Sincere Medical Device Co., Ltd.
Product code
Code MEG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Taipei City, TW
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.