K092430

Substantially Equivalent

1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES

Applicant: Inviro Medical Devices, Inc.
Product code: MEG
Advisory panel: General Hospital
Date received: 2009-08-07
Decision date: 2009-09-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Lawrenceville, GA, US

Adverse events under product code MEG

product code MEG

Malfunction: 1,373
Other: 1
Total: 1,374

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.