K-PACK II NEEDLE- 27G & 30G THIN WALL— 510(k) K110850

Substantially Equivalent

Terumo Europe N.V.

FDA 510(k) clearance K110850 for K-PACK II NEEDLE- 27G & 30G THIN WALL, Substantially Equivalent on 2011-06-09. Applicant: Terumo Europe N.V..

Clearance details

Applicant: Terumo Europe N.V.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2011-03-28
Decision date: 2011-06-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Leuven, BE

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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.