MED-LOK— 510(k) K093176

Substantially Equivalent

Sta-Med, LLC

FDA 510(k) clearance K093176 for MED-LOK, Substantially Equivalent on 2010-04-06. Applicant: Sta-Med, LLC.

Clearance details

Applicant
Sta-Med, LLC
Product code
Code MEG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, 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.