ENFit Oral / Enteral Syringe— 510(k) K190502

Substantially Equivalent

Jiangsu Caina Medical Co.,Ltd

FDA 510(k) clearance K190502 for ENFit Oral / Enteral Syringe, Substantially Equivalent on 2019-08-06. Applicant: Jiangsu Caina Medical Co.,Ltd.

Clearance details

Applicant
Jiangsu Caina Medical Co.,Ltd
Product code
Code PNR
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Jiangyin, CN
Download summary PDFView on FDA.gov ↗

Adverse events under product code PNR

product code PNR
Other
6
Total
6

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.