SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5— 510(k) K031065

Substantially Equivalent

Syringex Medical, Inc.

FDA 510(k) clearance K031065 for SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5, Substantially Equivalent on 2003-06-23. Applicant: Syringex Medical, Inc..

Clearance details

Applicant
Syringex Medical, Inc.
Product code
Code MEG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Draper, UT, US
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.