DISPOSABLE INTROSSEOUS INFUSION NEEDLES— 510(k) K913258

Clearance details

Applicant

Cook, Inc.

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

1991-07-23

Decision date

1992-03-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bloomington, IN, US

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• K261829 — Profoject Dual-Safety Pen Needles2026-07-29
• K260739 — Profoject Pen Needles (Model A; Model B)2026-07-15

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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 →