MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE— 510(k) K980062

Substantially Equivalent

Davis & Geck, Inc.

FDA 510(k) clearance K980062 for MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE, Substantially Equivalent on 1998-03-20. Applicant: Davis & Geck, Inc..

Clearance details

Applicant: Davis & Geck, Inc.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 1998-01-07
Decision date: 1998-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazlewood, MO, 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.