DR Safety Syringe, Sterile Hypodermic needle for Single use— 510(k) K212226

Substantially Equivalent

Zhuhai DR Medical Instruments Co., Ltd.

FDA 510(k) clearance K212226 for DR Safety Syringe, Sterile Hypodermic needle for Single use, Substantially Equivalent on 2021-09-29. Applicant: Zhuhai DR Medical Instruments Co., Ltd..

Clearance details

Applicant
Zhuhai DR Medical Instruments Co., Ltd.
Product code
Code MEG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Zhuhai, 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.