MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA— 510(k) K960982

Clearance details

Applicant

Sherwood Medical Co.

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

1996-03-11

Decision date

1996-12-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

St. Louis, MO, US

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• K960632 — KANGAROO FEEDING TUBE PLACMENT STYLET1996-05-09

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 →