MONOJECT INSULIN SYRINGE— 510(k) K033373

Substantially Equivalent

Tyco Healthcare

FDA 510(k) clearance K033373 for MONOJECT INSULIN SYRINGE, Substantially Equivalent on 2003-11-13. Applicant: Tyco Healthcare.

Clearance details

Applicant: Tyco Healthcare
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2003-10-22
Decision date: 2003-11-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.